Trial Outcomes & Findings for Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma (NCT NCT02335983)
NCT ID: NCT02335983
Last Updated: 2020-11-06
Results Overview
Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events. An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
COMPLETED
PHASE1
107 participants
From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
2020-11-06
Participant Flow
This study was conducted at 21 centers in the United States. The study had 2 parts: dose-evaluation and dose-expansion.
A Cohort Safety Review Committee (CSRC) reviewed all safety data and made recommendations regarding ongoing enrollment and opening of subsequent cohorts during the dose-evaluation component. The CSRC also selected the dose regimens evaluated in the dose-expansion component.
Participant milestones
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
34
|
9
|
9
|
33
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
32
|
9
|
8
|
32
|
Reasons for withdrawal
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
1
|
3
|
9
|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Specified Criteria
|
5
|
7
|
27
|
7
|
5
|
21
|
Baseline Characteristics
Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=9 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 6.5 • n=21 Participants
|
60.4 years
STANDARD_DEVIATION 10.7 • n=10 Participants
|
61.7 years
STANDARD_DEVIATION 10.6 • n=115 Participants
|
|
Age, Customized
< 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
64 Participants
n=115 Participants
|
|
Age, Customized
65 to 74 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Age, Customized
≥ 75 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
62 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
96 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
81 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.Population: All participants who received at least 1 dose of study drug (safety analysis set).
Safety and tolerability were evaluated according to the type, incidence, and severity of adverse events. An AE is defined as any untoward medical occurrence in a clinical trial subject. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event The severity of each AE was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=9 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event (AE)
|
10 Participants
|
12 Participants
|
34 Participants
|
9 Participants
|
9 Participants
|
33 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AE Grade ≥ 3
|
7 Participants
|
9 Participants
|
23 Participants
|
5 Participants
|
6 Participants
|
21 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
4 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation of carfilzomib
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation of lenalidomide
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation of dexamethasone
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Fatal adverse events
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related adverse events (TRAE)
|
9 Participants
|
11 Participants
|
30 Participants
|
9 Participants
|
9 Participants
|
32 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AEs Grade ≥ 3
|
6 Participants
|
8 Participants
|
18 Participants
|
5 Participants
|
5 Participants
|
18 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related serious adverse events
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
TRAEs leading to discontinuation of carfilzomib
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
TRAEs leading to discontinuation of lenalidomide
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
TRAEs leading to discontinuation of dexamethasone
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related fatal adverse events
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15Population: Participants in the safety analysis set with available data at Baseline and each time point.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=8 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin Levels
Baseline
|
116.90 g/L
Standard Deviation 14.58
|
120.67 g/L
Standard Deviation 13.51
|
123.24 g/L
Standard Deviation 16.57
|
111.50 g/L
Standard Deviation 18.04
|
120.00 g/L
Standard Deviation 20.96
|
113.21 g/L
Standard Deviation 16.66
|
—
|
—
|
|
Change From Baseline in Hemoglobin Levels
Change from Baseline to Cycle 1 Day 8
|
-1.50 g/L
Standard Deviation 7.52
|
-3.33 g/L
Standard Deviation 6.39
|
-0.91 g/L
Standard Deviation 5.46
|
-1.25 g/L
Standard Deviation 8.17
|
-5.56 g/L
Standard Deviation 6.11
|
-1.82 g/L
Standard Deviation 7.21
|
—
|
—
|
|
Change From Baseline in Hemoglobin Levels
Change from Baseline to Cycle 1 Day 15
|
-6.90 g/L
Standard Deviation 8.61
|
-9.50 g/L
Standard Deviation 6.29
|
-5.10 g/L
Standard Deviation 7.88
|
-1.75 g/L
Standard Deviation 12.70
|
-6.50 g/L
Standard Deviation 10.20
|
-5.64 g/L
Standard Deviation 9.10
|
—
|
—
|
|
Change From Baseline in Hemoglobin Levels
Change from Baseline to Cycle 2 Day 1
|
-5.70 g/L
Standard Deviation 9.78
|
-9.25 g/L
Standard Deviation 8.67
|
-7.38 g/L
Standard Deviation 7.76
|
-3.75 g/L
Standard Deviation 12.65
|
-3.29 g/L
Standard Deviation 9.60
|
2.19 g/L
Standard Deviation 10.59
|
—
|
—
|
|
Change From Baseline in Hemoglobin Levels
Change from Baseline to Cycle 2 Day 8
|
-6.00 g/L
Standard Deviation 11.91
|
-8.17 g/L
Standard Deviation 9.00
|
-5.59 g/L
Standard Deviation 8.35
|
-0.13 g/L
Standard Deviation 14.64
|
-2.86 g/L
Standard Deviation 8.49
|
4.19 g/L
Standard Deviation 12.41
|
—
|
—
|
|
Change From Baseline in Hemoglobin Levels
Change from Baseline to Cycle 2 Day 15
|
-8.50 g/L
Standard Deviation 12.47
|
-11.33 g/L
Standard Deviation 8.04
|
-8.45 g/L
Standard Deviation 10.08
|
0.00 g/L
Standard Deviation 14.05
|
-5.14 g/L
Standard Deviation 13.58
|
2.97 g/L
Standard Deviation 13.04
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15Population: Participants in the safety analysis set with available data at Baseline and each time point.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=8 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Platelet Count
Baseline
|
151.60 10^9 cells/L
Standard Deviation 54.40
|
202.50 10^9 cells/L
Standard Deviation 67.13
|
172.38 10^9 cells/L
Standard Deviation 33.70
|
214.00 10^9 cells/L
Standard Deviation 79.22
|
242.89 10^9 cells/L
Standard Deviation 99.24
|
233.03 10^9 cells/L
Standard Deviation 67.76
|
—
|
—
|
|
Change From Baseline in Platelet Count
Change from Baseline to Cycle 1 Day 8
|
-12.90 10^9 cells/L
Standard Deviation 29.88
|
-49.50 10^9 cells/L
Standard Deviation 58.90
|
-17.36 10^9 cells/L
Standard Deviation 21.75
|
2.38 10^9 cells/L
Standard Deviation 63.66
|
-51.11 10^9 cells/L
Standard Deviation 42.10
|
-21.42 10^9 cells/L
Standard Deviation 36.40
|
—
|
—
|
|
Change From Baseline in Platelet Count
Change from Baseline to Cycle 1 Day 15
|
-58.60 10^9 cells/L
Standard Deviation 32.76
|
-66.83 10^9 cells/L
Standard Deviation 87.14
|
-66.39 10^9 cells/L
Standard Deviation 38.30
|
-23.25 10^9 cells/L
Standard Deviation 116.67
|
-101.88 10^9 cells/L
Standard Deviation 84.66
|
-53.39 10^9 cells/L
Standard Deviation 43.60
|
—
|
—
|
|
Change From Baseline in Platelet Count
Change from Baseline to Cycle 2 Day 1
|
55.00 10^9 cells/L
Standard Deviation 38.61
|
68.67 10^9 cells/L
Standard Deviation 84.62
|
44.84 10^9 cells/L
Standard Deviation 52.82
|
141.75 10^9 cells/L
Standard Deviation 92.68
|
152.00 10^9 cells/L
Standard Deviation 244.50
|
111.06 10^9 cells/L
Standard Deviation 84.26
|
—
|
—
|
|
Change From Baseline in Platelet Count
Change from Baseline to Cycle 2 Day 8
|
-44.10 10^9 cells/L
Standard Deviation 38.14
|
-74.75 10^9 cells/L
Standard Deviation 86.91
|
-71.06 10^9 cells/L
Standard Deviation 37.93
|
-28.00 10^9 cells/L
Standard Deviation 111.10
|
-106.29 10^9 cells/L
Standard Deviation 130.18
|
-52.78 10^9 cells/L
Standard Deviation 60.70
|
—
|
—
|
|
Change From Baseline in Platelet Count
Change from Baseline to Cycle 2 Day 15
|
-44.40 10^9 cells/L
Standard Deviation 21.48
|
-63.25 10^9 cells/L
Standard Deviation 72.53
|
-60.13 10^9 cells/L
Standard Deviation 43.37
|
-21.25 10^9 cells/L
Standard Deviation 82.11
|
-76.14 10^9 cells/L
Standard Deviation 116.02
|
-44.19 10^9 cells/L
Standard Deviation 64.73
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15Population: Participants in the safety analysis set with available data at each time point.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=8 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Neutrophil Count
Baseline
|
2.53 10^9 cells/L
Standard Deviation 1.01
|
3.40 10^9 cells/L
Standard Deviation 1.54
|
2.72 10^9 cells/L
Standard Deviation 0.94
|
3.04 10^9 cells/L
Standard Deviation 0.73
|
3.24 10^9 cells/L
Standard Deviation 2.24
|
3.26 10^9 cells/L
Standard Deviation 1.46
|
—
|
—
|
|
Change From Baseline in Neutrophil Count
Change from Baseline to Cycle 1 Day 8
|
0.02 10^9 cells/L
Standard Deviation 0.82
|
0.03 10^9 cells/L
Standard Deviation 1.87
|
0.97 10^9 cells/L
Standard Deviation 1.19
|
0.59 10^9 cells/L
Standard Deviation 1.20
|
-0.19 10^9 cells/L
Standard Deviation 1.25
|
0.37 10^9 cells/L
Standard Deviation 1.29
|
—
|
—
|
|
Change From Baseline in Neutrophil Count
Change from Baseline to Cycle 1 Day 15
|
0.28 10^9 cells/L
Standard Deviation 1.14
|
-0.09 10^9 cells/L
Standard Deviation 1.94
|
0.81 10^9 cells/L
Standard Deviation 1.09
|
1.08 10^9 cells/L
Standard Deviation 1.53
|
0.43 10^9 cells/L
Standard Deviation 1.83
|
0.09 10^9 cells/L
Standard Deviation 1.48
|
—
|
—
|
|
Change From Baseline in Neutrophil Count
Change from Baseline to Cycle 2 Day 1
|
0.36 10^9 cells/L
Standard Deviation 1.99
|
-0.33 10^9 cells/L
Standard Deviation 1.59
|
0.16 10^9 cells/L
Standard Deviation 1.15
|
0.02 10^9 cells/L
Standard Deviation 0.58
|
0.09 10^9 cells/L
Standard Deviation 2.46
|
0.18 10^9 cells/L
Standard Deviation 0.95
|
—
|
—
|
|
Change From Baseline in Neutrophil Count
Change from Baseline to Cycle 2 Day 8
|
0.18 10^9 cells/L
Standard Deviation 0.68
|
-0.67 10^9 cells/L
Standard Deviation 1.28
|
0.63 10^9 cells/L
Standard Deviation 1.08
|
0.57 10^9 cells/L
Standard Deviation 1.05
|
0.46 10^9 cells/L
Standard Deviation 2.49
|
0.41 10^9 cells/L
Standard Deviation 1.25
|
—
|
—
|
|
Change From Baseline in Neutrophil Count
Change from Baseline to Cycle 2 Day 15
|
-0.30 10^9 cells/L
Standard Deviation 0.71
|
-0.54 10^9 cells/L
Standard Deviation 1.69
|
-0.06 10^9 cells/L
Standard Deviation 1.25
|
0.33 10^9 cells/L
Standard Deviation 0.53
|
0.56 10^9 cells/L
Standard Deviation 2.92
|
0.42 10^9 cells/L
Standard Deviation 2.00
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Cycle 2 day 1Population: Participants in the safety analysis set with available data at each time point.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=8 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin
Baseline
|
8.55 µmol/L
Standard Deviation 3.78
|
9.98 µmol/L
Standard Deviation 4.72
|
9.10 µmol/L
Standard Deviation 4.76
|
10.26 µmol/L
Standard Deviation 4.38
|
6.84 µmol/L
Standard Deviation 4.01
|
7.16 µmol/L
Standard Deviation 3.29
|
—
|
—
|
|
Change From Baseline in Bilirubin
Change from Baseline to Cycle 2 Day 1
|
0.86 µmol/L
Standard Deviation 3.25
|
1.00 µmol/L
Standard Deviation 3.68
|
1.34 µmol/L
Standard Deviation 3.52
|
3.42 µmol/L
Standard Deviation 5.56
|
0.49 µmol/L
Standard Deviation 2.91
|
1.21 µmol/L
Standard Deviation 3.10
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Cycle 1, days 8 and 15 and Cycle 2 days 1, 8, and 15Population: Participants in the safety analysis set with available data at each time point.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=8 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Creatinine
Change from Baseline to Cycle 1 Day 8
|
-2.65 µmol/L
Standard Deviation 5.05
|
-5.30 µmol/L
Standard Deviation 10.29
|
2.09 µmol/L
Standard Deviation 8.31
|
-1.22 µmol/L
Standard Deviation 8.25
|
-8.51 µmol/L
Standard Deviation 29.44
|
-0.22 µmol/L
Standard Deviation 12.89
|
—
|
—
|
|
Change From Baseline in Creatinine
Change from Baseline to Cycle 1 Day 15
|
-4.42 µmol/L
Standard Deviation 7.92
|
-4.60 µmol/L
Standard Deviation 11.32
|
-1.85 µmol/L
Standard Deviation 12.69
|
3.65 µmol/L
Standard Deviation 27.29
|
29.39 µmol/L
Standard Deviation 130.24
|
0.42 µmol/L
Standard Deviation 17.59
|
—
|
—
|
|
Change From Baseline in Creatinine
Change from Baseline to Cycle 2 Day 15
|
-6.28 µmol/L
Standard Deviation 10.29
|
-13.26 µmol/L
Standard Deviation 9.05
|
4.88 µmol/L
Standard Deviation 13.78
|
-12.38 µmol/L
Standard Deviation 6.90
|
-21.85 µmol/L
Standard Deviation 39.17
|
-1.99 µmol/L
Standard Deviation 18.08
|
—
|
—
|
|
Change From Baseline in Creatinine
Baseline
|
80.18 µmol/L
Standard Deviation 18.57
|
82.88 µmol/L
Standard Deviation 22.01
|
79.09 µmol/L
Standard Deviation 17.61
|
75.80 µmol/L
Standard Deviation 7.78
|
95.37 µmol/L
Standard Deviation 41.17
|
80.60 µmol/L
Standard Deviation 21.56
|
—
|
—
|
|
Change From Baseline in Creatinine
Change from Baseline to Cycle 2 Day 1
|
-3.80 µmol/L
Standard Deviation 6.81
|
-7.74 µmol/L
Standard Deviation 11.98
|
-1.44 µmol/L
Standard Deviation 9.66
|
-10.39 µmol/L
Standard Deviation 10.05
|
-17.17 µmol/L
Standard Deviation 36.71
|
-4.31 µmol/L
Standard Deviation 9.84
|
—
|
—
|
|
Change From Baseline in Creatinine
Change from Baseline to Cycle 2 Day 8
|
-6.45 µmol/L
Standard Deviation 4.97
|
-11.09 µmol/L
Standard Deviation 12.70
|
1.85 µmol/L
Standard Deviation 10.95
|
-12.27 µmol/L
Standard Deviation 8.20
|
-20.08 µmol/L
Standard Deviation 37.86
|
-4.32 µmol/L
Standard Deviation 9.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusionPopulation: Participants who received at least 1 dose of study drug who had sufficient carfilzomib exposure and plasma concentration versus time data for the estimation of pharmacokinetic parameters by a non-compartmental analysis on day 8 of cycle 1.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=46 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=40 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
|
11700 ng/mL
Standard Deviation 67300
|
12400 ng/mL
Standard Deviation 45000
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusionPopulation: Participants who received at least 1 dose of study drug who had sufficient carfilzomib exposure and plasma concentration versus time data for the estimation of pharmacokinetic parameters by a non-compartmental analysis on day 8 of cycle 1.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=46 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=40 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
|
0.28 hours
Interval 0.17 to 24.0
|
0.27 hours
Interval 0.17 to 0.68
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusionPopulation: Participants who received at least 1 dose of study drug who had sufficient carfilzomib exposure and plasma concentration versus time data for the estimation of pharmacokinetic parameters by a non-compartmental analysis on day 8 of cycle 1.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=46 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=40 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group
|
4150 hr*ng/mL
Standard Deviation 17500
|
9130 hr*ng/mL
Standard Deviation 32800
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.Population: All participants who received at least 1 dose of study drug
Response was determined by the investigator based on the International Myeloma Working Group Uniform Response Criteria (IMWG URC). ORR was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Responses must have been confirmed in 2 consecutive assessments at any time prior to initiation of any new therapy. Disease assessments included serum protein electrophoresis (SPEP) with immunofixation, urine protein electrophoresis (UPEP; 24-hour assessment) with immunofixation, serum free light chain (SFLC), quantitative immunoglobulins, bone marrow aspirates to determine percent plasma cell involvement, and skeletal imaging for plasmacytoma evaluation.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=46 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
n=18 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
90.0 percentage of participants
Interval 55.5 to 99.7
|
91.7 percentage of participants
Interval 61.5 to 99.8
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
89.1 percentage of participants
Interval 76.4 to 96.4
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
97.0 percentage of participants
Interval 84.2 to 99.9
|
SECONDARY outcome
Timeframe: Response assessments were performed on day 1 of each treatment cycle from cycle 2 and then every 8 weeks during follow-up until disease progression. Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.Population: Participants who received at least 1 dose of study drug.
Complete Response Rate (CRR) is defined as the percentage of participants who achieved a best overall response of either stringent complete response (sCR) or complete response (CR) in accordance with International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM) CR: Negative serum and urine immunofixation, disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in BM, and normal SFLC ratio in participants with measurable disease only by SFLC.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=46 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
n=18 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Complete Response Rate (CRR)
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
26.5 percentage of participants
Interval 12.9 to 44.4
|
23.9 percentage of participants
Interval 12.6 to 38.8
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
16.7 percentage of participants
Interval 3.6 to 41.4
|
33.3 percentage of participants
Interval 18.0 to 51.8
|
SECONDARY outcome
Timeframe: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.Population: Participants who received at least 1 dose of study drug
PFS is defined as the time from the first day of study treatment to the earlier of disease progression or death due to any cause. Disease progression was determined by the investigator according to IMWG-URC. Progressive Disease (PD): Increase of 25% from lowest value in serum M-component (absolute increase ≥ 0.5 g/dL), urine M-component (absolute increase ≥ 200 mg per 24 hours) and/or the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL) in patients without measurable serum and urine M-protein levels, and/or any new or increase in size of bone lesions or soft tissue plasmacytomas, or development of hypercalcemia. PFS was analyzed using Kaplan-Meier methods. Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after \> 1 consecutively missed assessment visit, were lost to follow-up or withdrew consent were censored at the date of last disease assessment.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=46 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=9 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
n=18 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
NA months
Interval 14.8 to
Could not be estimated due to the low number of events
|
NA months
Interval 5.6 to
Could not be estimated due to the low number of events
|
NA months
Interval 21.1 to
Could not be estimated due to the low number of events
|
NA months
Interval 21.1 to
Could not be estimated due to the low number of events
|
NA months
Interval 4.7 to
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From first dose of study drug until the end of follow-up; Median time on follow-up was 10.6 months in RRMM participants and 6.9 months in NDMM participants.Population: Participants who received at least 1 dose of study drug with an overall response of PR or better.
Duration of response (DOR) was calculated for participants who achieved a confirmed PR or better based on Investigator assessment and according to the IMWG URC. Duration of overall response is defined as the time from first documentation of response to disease progression or death due to any cause. DOR was analyzed using Kaplan-Meier methods. Participants who were alive with no documented PD, started new anticancer therapy before documentation of PD or death, had death or PD immediately after \> 1 consecutively missed disease assessment visit, were lost to follow-up, or withdrew consent were censored at the date of last disease assessment.
Outcome measures
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=9 Participants
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=11 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=30 Participants
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=41 Participants
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=8 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=7 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM: Combined Carfilzomib 70 mg/m²
n=15 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, 56 or 70 mg/m² on cycle 1 days 8 and 15, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=32 Participants
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA months
Could not be estimated due to the low number of events
|
NA months
Interval 11.6 to
Could not be estimated due to the low number of events
|
NA months
Interval 20.2 to
Could not be estimated due to the low number of events
|
NA months
Interval 20.2 to
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
NA months
Could not be estimated due to the low number of events
|
Adverse Events
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
RRMM Dose-expansion: Carfilzomib 70 mg/m²
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
NDMM Dose-expansion: Carfilzomib 70 mg/m²
NDMM Dose-expansion: Carfilzomib 56 mg/m²
Serious adverse events
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 participants at risk
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 participants at risk
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 participants at risk
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=9 participants at risk
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 participants at risk
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 participants at risk
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Strangulated hernia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Device related infection
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Orchitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
Other adverse events
| Measure |
RRMM Dose-evaluation: Carfilzomib 56 mg/m²
n=10 participants at risk
Participants with relapsed or refractory multiple myeloma (RRMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-evaluation: Carfilzomib 70 mg/m²
n=12 participants at risk
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
RRMM Dose-expansion: Carfilzomib 70 mg/m²
n=34 participants at risk
Participants with RRMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-evaluation: Carfilzomib 56/70 mg/m²
n=9 participants at risk
Participants with newly diagnosed multiple myeloma (NDMM) received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1 day 1, 56 mg/m² on cycle 1 days 8 and 15, and then 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 70 mg/m²
n=9 participants at risk
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 70 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
NDMM Dose-expansion: Carfilzomib 56 mg/m²
n=33 participants at risk
Participants with NDMM received treatment with carfilzomib, lenalidomide, and dexamethasone (KRd) for up to eighteen 28-day cycles, or until disease progression, patient withdrawal, stem cell transplant, or death.
Participants received carfilzomib on days 1, 8, and 15 of each cycle. The dose was 20 mg/m² on cycle 1, day 1, and 56 mg/m² thereafter. Participants also received lenalidomide 25 mg once daily on days 1-21 and dexamethasone 40 mg (oral or IV) on days 1, 8, and 15 of each cycle, and on day 22 of cycles 1 to 8.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
26.5%
9/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
27.3%
9/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Haemolysis
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
4/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
17.6%
6/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Ear and labyrinth disorders
Hypoacusis
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Eye disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Eye swelling
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Halo vision
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
58.3%
7/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
20.6%
7/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
55.6%
5/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
30.3%
10/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
50.0%
6/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
52.9%
18/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
77.8%
7/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
66.7%
6/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
48.5%
16/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
24.2%
8/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Haematochezia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
35.3%
12/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
51.5%
17/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
17.6%
6/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Administration site oedema
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Asthenia
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Chest discomfort
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Chest pain
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Chills
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Cyst
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Energy increased
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Fatigue
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
4/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
61.8%
21/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
39.4%
13/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Localised oedema
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Malaise
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Oedema
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Oedema peripheral
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
11/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Pain
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Pyrexia
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Swelling
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Swelling face
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
General disorders
Thirst
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Immune system disorders
Seasonal allergy
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Candida infection
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Clostridium difficile infection
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Implant site abscess
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Sinusitis
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Tinea infection
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
58.3%
7/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
41.2%
14/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
45.5%
15/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
21.2%
7/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Blood creatinine increased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Blood urine present
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Globulins increased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
32.4%
11/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Investigations
White blood cell count decreased
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
23.5%
8/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
24.2%
8/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
23.5%
8/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
50.0%
6/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
29.4%
10/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
24.2%
8/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
26.5%
9/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
36.4%
12/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.8%
4/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Burning sensation
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Disturbance in attention
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Dizziness
|
50.0%
5/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
20.6%
7/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
36.4%
12/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
21.2%
7/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
23.5%
8/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
3/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
55.6%
5/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
39.4%
13/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Nervous system disorders
Tremor
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Insomnia
|
40.0%
4/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
20.6%
7/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
51.5%
17/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Mania
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Pollakiuria
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
41.7%
5/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
32.4%
11/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
36.4%
12/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
4/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
4/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
26.5%
9/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
30.3%
10/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.8%
3/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
25.0%
3/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
17.6%
6/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
15.2%
5/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
17.6%
6/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
18.2%
6/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
9.1%
3/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
11/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
16.7%
2/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
14.7%
5/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
44.4%
4/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
24.2%
8/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
12.1%
4/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Deep vein thrombosis
|
30.0%
3/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Femoral artery aneurysm
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
2.9%
1/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
33.3%
4/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
20.6%
7/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
22.2%
2/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
3.0%
1/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
5.9%
2/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
8.3%
1/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Thrombophlebitis superficial
|
10.0%
1/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
6.1%
2/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
|
Vascular disorders
Vein discolouration
|
0.00%
0/10 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/12 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/34 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
11.1%
1/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/9 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
0.00%
0/33 • All-cause Mortality is reported from the enrollment date up to the end of study; maximum time on study was 30.6 months. Treatment-emergent adverse events are reported from the first dose of any study drug up to 30 days after the last dose of any study drug; median (range) duration of treatment with carfilzomib was 32 (1.1, 76.7) weeks in RRMM participants and 26 (1.0, 94.4) weeks in NDMM participants.
|
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