Trial Outcomes & Findings for Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma (NCT NCT02939183)
NCT ID: NCT02939183
Last Updated: 2024-09-26
Results Overview
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
COMPLETED
PHASE1
61 participants
Day 1 to day 28 of cycle 1, where each cycle was 28 days
2024-09-26
Participant Flow
Participants were enrolled at 26 research centers in Australia, Canada, Spain, and the United States, and participated from 17 January 2017 to 06 October 2022.
Part 1 evaluated oprozomib formulations (immediate-release \[IR\] and gastro-retentive \[GR\]) administered at a 150 mg/day dose level with dexamethasone. Part 2 evaluated the IR and GR oprozomib formulations administered at different increasing dose levels with pomalidomide and dexamethasone. An open-label roll-over part was conducted in the United States to include eligible participants from separate Amgen oprozomib studies in a single arm as pre-specified in the statistical analysis plan (SAP).
Participant milestones
| Measure |
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Open-label Roll-over
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
3
|
5
|
9
|
5
|
11
|
8
|
7
|
|
Overall Study
Received Oprozomib
|
5
|
8
|
3
|
4
|
9
|
5
|
10
|
8
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
2
|
2
|
7
|
3
|
4
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
3
|
2
|
2
|
7
|
3
|
6
|
Reasons for withdrawal
| Measure |
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Open-label Roll-over
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Sponsor decision
|
0
|
1
|
0
|
1
|
2
|
0
|
3
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
0
|
0
|
2
|
2
|
2
|
|
Overall Study
Not treated due to adverse event
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Oprozomib IR 150 mg/Day + Dexamethsone
n=5 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=8 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Open-label Roll-over
n=7 Participants
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
64.3 years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
62.0 years
STANDARD_DEVIATION 8.2 • n=8 Participants
|
63.1 years
STANDARD_DEVIATION 10.2 • n=8 Participants
|
65.9 years
STANDARD_DEVIATION 10.5 • n=24 Participants
|
70.4 years
STANDARD_DEVIATION 8.7 • n=42 Participants
|
63.6 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to day 28 of cycle 1, where each cycle was 28 daysPopulation: DLT-evaluable participants received the following during the 28-day DLT window: all planned doses of oprozomib, a minimum of 17 of 21 planned doses of pomalidomide, and a minimum of 6 of 8 planned doses of dexamethasone. One participant enrolled in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone, and this participant was included in the Oprozomib IR 150 mg + pomalidomide + dexamethasone arm.
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=5 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=8 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxcity (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28 of cycle 1, where each cycle was 28 daysPopulation: DLT-evaluable participants in Part 2 who received the following during the 28-day DLT window: all planned doses of oprozomib, a minimum of 17 of 21 planned doses of pomalidomide, and a minimum of 6 of 8 planned doses of dexamethasone.
The MTD was the dose with the highest posterior probability of having a DLT rate within the target toxicity interval (15% to 25%), while the posterior probability of excessive/unacceptable toxicity (\>25% to 100%) is \<40%. DLTs were graded using CTCAE version 4.03 and included the below, if judged by the investigator/medical monitor to be possibly related to study treatment: Non-hematologic DLTs were any ≥ Grade 3 toxicity, except: Grade 3 asymptomatic electrolyte abnormalities (except hypophosphatemia \> 24 hours); Grade 3 nausea, vomiting and diarrhea \< 3 days; Grade 3 fatigue \< 14 days; ≥ Grade 3 hyperglycemia/toxicity due to dexamethasone; ≥ Grade 3 rash due to pomalidomide. Hematologic DLTs included: Grade 4 neutropenia if absolute neutrophil count \< 0.5 x 10\^9/L ≥ 7 days; febrile neutropenia; Grade 4 thrombocytopenia ≥ 7 days; Grade ≥ 3 with ≥ Grade 2 bleeding/requiring platelet transfusion.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=30 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=9 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Each Formulation of Oprozomib in Combination With Pomolidomide and Dexamethasone
|
—
|
250 mg/day
|
NA mg/day
The MTD for oprozomib GR in combination with pomalidomide and dexamethasone was not determined due to too few DLTs.
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 of cycle 1 to 30 (+7) days after the last dose of study treatment or end of study date, whichever is earlier (where each cycle was 28 days). Median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: Participants in the safety analysis set who received any amount of oprozomib, pomalidomide and/or dexamethasone in Parts 1 and 2.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment and clinical laboratory tests were recorded as TEAEs.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=5 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=8 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Oprozomib in Combination With Dexamethasone and/or Pomalidomide)
Any TEAE
|
5 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Oprozomib in Combination With Dexamethasone and/or Pomalidomide)
Any Treatment-related TEAE
|
5 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 30 (+7) days after the last dose of study treatment or end of study date, whichever is earlier (where each cycle was 28 days). Median treatment duration for the open-label roll-over arm was 75.14 weeksPopulation: The safety analysis set for roll-over participants included all roll-over participants who received any amount of oprozomib, pomalidomide and/or dexamethasone. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
TEAEs were any AE that started on or after receiving the first dose of investigational product and up to and including 30 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered related to study treatment by the investigator. Serious TEAEs were any AE meeting at least 1 of the following criteria: fatal; life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=7 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs and Treatment-emergent Serious AEs (Open-label Roll-over)
Any TEAE
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs and Treatment-emergent Serious AEs (Open-label Roll-over)
Any Serious TEAE
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dosePopulation: Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
The mean Cmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Oprozomib
Cycle 1 Day 22
|
137 ng/mL
Standard Deviation 81.1
|
453 ng/mL
Standard Deviation 48.0
|
209 ng/mL
Standard Deviation 185
|
305 ng/mL
Standard Deviation NA
Standard deviation (SD) could not be determined due to too few participants with available data at this time point.
|
191 ng/mL
Standard Deviation 99.2
|
1040 ng/mL
Standard Deviation 941
|
1580 ng/mL
Standard Deviation 672
|
1420 ng/mL
Standard Deviation 1250
|
|
Maximum Observed Concentration (Cmax) of Oprozomib
Cycle 1 Day 8
|
367 ng/mL
Standard Deviation 429
|
321 ng/mL
Standard Deviation 89.2
|
118 ng/mL
Standard Deviation 90.3
|
349 ng/mL
Standard Deviation 195
|
119 ng/mL
Standard Deviation 77.7
|
694 ng/mL
Standard Deviation 479
|
1020 ng/mL
Standard Deviation 911
|
800 ng/mL
Standard Deviation 703
|
SECONDARY outcome
Timeframe: Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dosePopulation: Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
The median Tmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Oprozomib
Cycle 1 Day 8
|
2.0 hours
Interval 1.1 to 5.8
|
1.0 hours
Interval 0.93 to 1.9
|
2.0 hours
Interval 2.0 to 4.0
|
2.0 hours
Interval 0.5 to 2.0
|
5.8 hours
Interval 3.9 to 6.0
|
2.0 hours
Interval 0.45 to 6.0
|
1.5 hours
Interval 0.47 to 4.2
|
1.3 hours
Interval 0.42 to 5.8
|
|
Time to Cmax (Tmax) of Oprozomib
Cycle 1 Day 22
|
4.8 hours
Interval 2.0 to 6.0
|
1.0 hours
Interval 0.98 to 2.0
|
3.0 hours
Interval 1.9 to 6.0
|
1.0 hours
Interval 1.0 to 1.0
|
4.1 hours
Interval 3.7 to 6.0
|
1.3 hours
Interval 0.45 to 2.0
|
0.98 hours
Interval 0.42 to 2.2
|
0.75 hours
Interval 0.5 to 1.1
|
SECONDARY outcome
Timeframe: Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dosePopulation: Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
The mean AUClast of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Oprozomib
Cycle 1 Day 22
|
888 hour*ng/mL
Standard Deviation 1200
|
1020 hour*ng/mL
Standard Deviation 281
|
1380 hour*ng/mL
Standard Deviation 1090
|
681 hour*ng/mL
Standard Deviation NA
The SD could not be determined due to too few participants with available data at this time point.
|
839 hour*ng/mL
Standard Deviation 544
|
1420 hour*ng/mL
Standard Deviation 659
|
2050 hour*ng/mL
Standard Deviation 722
|
2030 hour*ng/mL
Standard Deviation 1070
|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Oprozomib
Cycle 1 Day 8
|
1880 hour*ng/mL
Standard Deviation 2190
|
656 hour*ng/mL
Standard Deviation 77.6
|
357 hour*ng/mL
Standard Deviation 252
|
869 hour*ng/mL
Standard Deviation 449
|
655 hour*ng/mL
Standard Deviation 73.5
|
1210 hour*ng/mL
Standard Deviation 658
|
1730 hour*ng/mL
Standard Deviation 1160
|
1710 hour*ng/mL
Standard Deviation 1560
|
SECONDARY outcome
Timeframe: Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
BOR was the best response per IMWG-URC from best to worst: stringent complete response (sCR; complete response \[CR\], normal serum free light chain ratio, no clonal cells in bone marrow \[BM\]), CR (negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in BM), very good partial response (VGPR; serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein \[urine M-protein level \< 100 mg/24-h\]), partial response (PR; ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or \< 200 mg/24-h), minimal response (MR; 25-49% reduction of serum M-protein and 50-89% in 24-h urinary M-protein, exceeding 200 mg/24-h), stable disease (SD; not CR, VGPR, PR or progressive disease \[PD\]), and PD (≥ 25% increase in serum or urine M-component, development of new or increased size of existing bone lesions or soft tissue plasmacytomas, hypercalcemia attributed to the plasma cell proliferative disorder).
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
VGPR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
sCR
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
PR
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
MR
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
SD
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
PD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response (BOR) According to Revised International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Unconfirmed response
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
The ORR was defined as the percentage of participants with a BOR of sCR, CR, VGPR, and PR per the IMWG-URC. Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level \< 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to \< 200 mg/24-h. The 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) According to IMWG-URC
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0.0 percentage of participants
The 95% CIs could not be determined as no participants achieved OR.
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
SECONDARY outcome
Timeframe: Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
PFS was defined as the number of months from a participant's first dose of study treatment to the earlier of disease progression or death due to any cause. The number of participants who had a PFS event or who were censored are presented. PFS events were an assessment of progressive disease according to the IMWG-URC or death due to any cause. PFS data was censored: participants alive and no documented disease progression at time of analysis were censored at date of last disease assessment; participants alive with no disease assessment were censored at the first study dose date; participants alive without documented disease progression, with withdrawn consent were censored at date of last disease assessment before consent withdrawal; and for participants who started anti-cancer therapy other than study treatment prior to documentation of disease progression were censored at date of last disease assessment prior to starting new therapy.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Progression Free Survival (PFS) Events
Participants with PFS events
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Progression Free Survival (PFS) Events
Participants who were censored
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.
PFS was defined as the number of months from a participant's first dose of study treatment to the earlier of disease progression or death due to any cause. Median PFS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. PFS data was censored: participants alive and no documented disease progression at time of analysis were censored at date of last disease assessment; participants alive with no disease assessment were censored at the first study dose date; participants alive without documented disease progression, with withdrawn consent were censored at date of last disease assessment before consent withdrawal; and for participants who started anti-cancer therapy other than study treatment prior to documentation of disease progression were censored at date of last disease assessment prior to starting new therapy.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=3 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=6 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of PFS
|
NA months
Interval 1.5 to
The median and upper 95% CI could not be estimated due to too few events.
|
NA months
The median and upper and lower 95% CIs could not be estimated due to too few events.
|
NA months
Interval 2.7 to
The median and upper 95% CI could not be estimated due to too few events.
|
14.24 months
Due to the low numbers of participants (3) there are too few events (1) that impacted the estimate of survival function to no variation, hence the 95% CIs could not be estimated.
|
NA months
The median and upper and lower 95% CIs could not be estimated due to too few events.
|
NA months
The median and upper and lower 95% CIs could not be estimated due to too few events.
|
17.50 months
Interval 5.6 to
The upper 95% CI could not be estimated due to too few events.
|
NA months
Interval 29.5 to
The median and upper 95% CI could not be estimated due to too few events.
|
SECONDARY outcome
Timeframe: Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeksPopulation: The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment. Participants who did not achieve an objective response were excluded from the analysis of DOR. Participants who responded and had not progressed while on study were censored at the date of assessment of the last evaluable tumor assessment.
DOR, presented in months, was defined as the number of days between the date of the first tumor assessment indicating an objective response (PR or better) through to the subsequent date of progression or death due to any cause, or where applicable date of censoring (date of first progressive disease assessment or death or date of censoring - date of the first objective response result + 1/30.4). Median PFS was estimated using the Kaplan-Meier method. 95% confidence intervals were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Outcome measures
| Measure |
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=3 Participants
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 150 mg/Day + Dexamethsone
n=2 Participants
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=1 Participants
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=1 Participants
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=6 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=6 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=7 Participants
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Duration of Response (DOR)
|
NA months
The median, upper and lower 95% CIs could not be estimated due to too few events.
|
NA months
The median, upper and lower 95% CIs could not be estimated due to too few events.
|
NA months
The median, upper and lower 95% CIs could not be estimated due to too few events.
|
NA months
The median, upper and lower 95% CIs could not be estimated due to too few events.
|
—
|
NA months
The median, upper and lower 95% CIs could not be estimated due to too few events.
|
16.6 months
Interval 3.7 to
The upper 95% CI could not be estimated due to too few events.
|
NA months
Interval 28.6 to
The median could not be estimated due to too few events. The lower bound 95% CI was estimated from observed data that were available (25% percentile).
|
Adverse Events
Oprozomib IR 150 mg/Day + Dexamethsone
Oprozomib GR 150 mg/Day + Dexamethasone
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
Open-label Roll-over
Serious adverse events
| Measure |
Oprozomib IR 150 mg/Day + Dexamethsone
n=5 participants at risk
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=8 participants at risk
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 participants at risk
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=8 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 participants at risk
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle
|
Open-label Roll-over
n=7 participants at risk
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pasteurella infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
Other adverse events
| Measure |
Oprozomib IR 150 mg/Day + Dexamethsone
n=5 participants at risk
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib GR 150 mg/Day + Dexamethasone
n=8 participants at risk
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
|
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
n=4 participants at risk
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
n=8 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
n=5 participants at risk
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
n=10 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
|
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
n=8 participants at risk
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle
|
Open-label Roll-over
n=7 participants at risk
Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Blepharitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Diplopia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Eye discharge
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Eye disorder
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
4/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
6/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
62.5%
5/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
62.5%
5/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
80.0%
4/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
80.0%
8/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
100.0%
8/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
87.5%
7/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
6/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
80.0%
8/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
100.0%
8/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
6/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
70.0%
7/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
87.5%
7/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Asthenia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Catheter site bruise
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Chills
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Face oedema
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Fatigue
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
4/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
6/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
62.5%
5/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Feeling jittery
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
4/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Injection site bruising
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Localised oedema
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Malaise
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Oedema
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
5/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Pain
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Puncture site bruise
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Secretion discharge
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Swelling
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Immune system disorders
Immunisation reaction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Eye infection
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Moraxella infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Mucosal infection
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Paronychia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
62.5%
5/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Infections and infestations
Wound infection
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Amylase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood creatine increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Blood urine present
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Crystal urine present
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Norovirus test positive
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Troponin I increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
Weight increased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
3/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
75.0%
3/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
28.6%
2/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Myeloma cast nephropathy
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Pollakiuria
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
2/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
5/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
4/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
30.0%
3/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Surgical and medical procedures
Skin lesion removal
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
50.0%
4/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
2/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
10.0%
1/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Insomnia
|
40.0%
2/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
2/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
60.0%
6/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
37.5%
3/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Psychiatric disorders
Mood altered
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Acute kidney injury
|
20.0%
1/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
25.0%
1/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/4 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/5 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
0.00%
0/10 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
12.5%
1/8 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
14.3%
1/7 • Treatment-emergent adverse events were collected from the first dose of study treatment until the last dose + 30 days; median treatment duration in Part 1 was 11.43 weeks, in Part 2 was 28 weeks, and in the open-label roll-over arm was 75.14 weeks. All-cause mortality was collected from enrollment to end of study visit; median overall duration on study was 259.00 days.
Serious adverse events and other adverse events are reported for all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone (safety analysis set) and were collected according to treatment received. All-cause mortality is reported for all participants enrolled in the study and was collected according to assigned treatment group. Participants enrolled in this study from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER