Trial Outcomes & Findings for CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis (NCT NCT00558896)
NCT ID: NCT00558896
Last Updated: 2018-04-18
Results Overview
Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
378 participants
Primary outcome timeframe
Duration of study (up to 3 years)
Results posted on
2018-04-18
Participant Flow
Between November 2007 and March 2012, 7 sequential phase 2 trials (reported as separate arms) were conducted. A total of 378 participants were recruited at Mayo Clinic (Arizona, Florida or Arizona).
One patient was deemed ineligible and excluded from all analyses.
Participant milestones
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
34
|
35
|
35
|
60
|
120
|
33
|
|
Overall Study
COMPLETED
|
39
|
27
|
30
|
23
|
37
|
68
|
9
|
|
Overall Study
NOT COMPLETED
|
21
|
7
|
5
|
12
|
23
|
52
|
24
|
Reasons for withdrawal
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
3
|
4
|
10
|
3
|
|
Overall Study
Death
|
3
|
0
|
2
|
3
|
2
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
1
|
1
|
5
|
5
|
|
Overall Study
Alternative Treatment
|
2
|
2
|
0
|
2
|
6
|
7
|
1
|
|
Overall Study
Physician discretion
|
3
|
2
|
1
|
2
|
1
|
3
|
3
|
|
Overall Study
Continues on treatment
|
10
|
1
|
0
|
1
|
9
|
25
|
6
|
Baseline Characteristics
CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
Baseline characteristics by cohort
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=60 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=34 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=35 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=35 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=60 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=120 Participants
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=33 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
61.5 years
n=7 Participants
|
62 years
n=5 Participants
|
61 years
n=4 Participants
|
65.5 years
n=21 Participants
|
65 years
n=10 Participants
|
66 years
n=115 Participants
|
64 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
138 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
239 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
34 participants
n=7 Participants
|
35 participants
n=5 Participants
|
35 participants
n=4 Participants
|
60 participants
n=21 Participants
|
120 participants
n=10 Participants
|
33 participants
n=115 Participants
|
377 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Duration of study (up to 3 years)Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Outcome measures
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=60 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=34 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=35 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=35 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=60 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=120 Participants
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=33 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)
|
39 participants
|
11 participants
|
9 participants
|
10 participants
|
23 participants
|
25 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 5 years)PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method. Progression was defined as any one or more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25% increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas
Outcome measures
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=60 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=34 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=35 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=35 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=60 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=120 Participants
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=33 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
13 months
Interval 8.1 to 20.4
|
5 months
Interval 2.7 to 10.3
|
6.4 months
Interval 3.2 to 8.0
|
3.3 months
Interval 1.9 to 6.2
|
7.7 months
Interval 4.8 to 10.8
|
4.3 months
Interval 2.9 to 5.0
|
14.1 months
Interval 9.7 to 21.1
|
SECONDARY outcome
Timeframe: Duration of study (up to 5 years)Population: Participants who achieved a partial response(PR) or better were evaluable for this analysis.
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.
Outcome measures
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=39 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=11 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=9 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=10 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=23 Participants
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=25 Participants
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=16 Participants
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
21.3 months
Interval 11.2 to 34.1
|
8.2 months
Interval 3.2 to 38.4
|
15.6 months
Interval 4.3 to 31.1
|
3.1 months
Interval 1.8 to 14.5
|
NA months
Median duration of response was not attained
|
8.3 months
Interval 4.5 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
19 months
Interval 8.3 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
Adverse Events
Relapsed Myeloma (<4 Prior Regimens): Low Dose
Serious events: 22 serious events
Other events: 60 other events
Deaths: 0 deaths
Lenalidomide Refractory Myeloma: Low Dose
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
Serious events: 15 serious events
Other events: 34 other events
Deaths: 0 deaths
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
Serious events: 11 serious events
Other events: 35 other events
Deaths: 0 deaths
Relapsed Myeloma (< 4 Prior Regimens): High Dose
Serious events: 21 serious events
Other events: 60 other events
Deaths: 0 deaths
Relapsed/Refractory Myeloma: High Dose
Serious events: 32 serious events
Other events: 119 other events
Deaths: 0 deaths
Relapsed Amyloidosis: Low Dose
Serious events: 18 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=60 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=34 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=35 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=35 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=60 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=119 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=33 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
14.3%
5/35 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
4.2%
5/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Cardiac disorder
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Cardiac valve disease
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Cataract
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Eye disorder
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Cecum perforation
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Chest pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Death
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Fatigue
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Fever
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Multi-organ failure
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bladder infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bone infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Infectious meningitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Pneumonia
|
13.3%
8/60 • Number of events 10
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
17.6%
6/34 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
22.9%
8/35 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.7%
7/60 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
10.9%
13/119 • Number of events 13
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
18.2%
6/33 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Skin infection
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury - Joint
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Bilirubin increased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Creatinine increased
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
INR increased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.7%
4/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
4.2%
5/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
10.0%
6/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
4.2%
5/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Platelet count decreased
|
5.0%
3/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.7%
4/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
6/119 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Confusion
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Depression
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Hematoma
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Thrombosis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
Other adverse events
| Measure |
Relapsed Myeloma (<4 Prior Regimens): Low Dose
n=60 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Lenalidomide Refractory Myeloma: Low Dose
n=34 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
n=35 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
n=35 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Myeloma (< 4 Prior Regimens): High Dose
n=60 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed/Refractory Myeloma: High Dose
n=119 participants at risk
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
Relapsed Amyloidosis: Low Dose
n=33 participants at risk
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Insomnia
|
18.3%
11/60 • Number of events 17
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
15.0%
9/60 • Number of events 18
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.4%
4/119 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Bladder stenosis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
95.0%
57/60 • Number of events 707
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
100.0%
34/34 • Number of events 241
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
97.1%
34/35 • Number of events 239
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
97.1%
34/35 • Number of events 134
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
91.7%
55/60 • Number of events 348
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
96.6%
115/119 • Number of events 418
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
93.9%
31/33 • Number of events 277
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 11
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Cataract
|
3.3%
2/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Diplopia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Dry eye syndrome
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Eye disorder
|
1.7%
1/60 • Number of events 10
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Eye pain
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Night blindness
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Retinal detachment
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Vision blurred
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Constipation
|
18.3%
11/60 • Number of events 20
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.7%
4/60 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
26/60 • Number of events 71
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
32.4%
11/34 • Number of events 57
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
31.4%
11/35 • Number of events 47
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
22.9%
8/35 • Number of events 18
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
38.3%
23/60 • Number of events 73
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
25.2%
30/119 • Number of events 49
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
48.5%
16/33 • Number of events 44
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
19/60 • Number of events 38
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
29.4%
10/34 • Number of events 37
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
31.4%
11/35 • Number of events 46
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
20.0%
7/35 • Number of events 10
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
21.7%
13/60 • Number of events 37
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
26.1%
31/119 • Number of events 43
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
39.4%
13/33 • Number of events 32
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
10/60 • Number of events 16
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
17.6%
6/34 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
20.0%
7/35 • Number of events 28
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
10.0%
6/60 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
7/119 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
15.2%
5/33 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Disease progression
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Edema limbs
|
15.0%
9/60 • Number of events 19
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.8%
4/34 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.7%
4/60 • Number of events 14
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
21.2%
7/33 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Fatigue
|
93.3%
56/60 • Number of events 718
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
94.1%
32/34 • Number of events 278
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
88.6%
31/35 • Number of events 247
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
91.4%
32/35 • Number of events 127
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
93.3%
56/60 • Number of events 440
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
93.3%
111/119 • Number of events 372
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
97.0%
32/33 • Number of events 331
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Fever
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Irritability
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Localized edema
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
General disorders
Pain
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Abdominal infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Appendicitis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bone infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Infection
|
3.3%
2/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Pneumonia
|
11.7%
7/60 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
10.0%
6/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
7/119 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
6/60 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
14.7%
5/34 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Injury, poisoning and procedural complications
Intraoperative ocular injury
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Bilirubin increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Creatinine increased
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
INR increased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Leukocyte count decreased
|
73.3%
44/60 • Number of events 243
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
79.4%
27/34 • Number of events 92
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
82.9%
29/35 • Number of events 147
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
88.6%
31/35 • Number of events 122
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
90.0%
54/60 • Number of events 266
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
86.6%
103/119 • Number of events 303
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
66.7%
22/33 • Number of events 96
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
6/60 • Number of events 69
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.8%
4/34 • Number of events 10
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
34.3%
12/35 • Number of events 48
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
40.0%
14/35 • Number of events 41
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
53.3%
32/60 • Number of events 130
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.7%
8/119 • Number of events 22
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 11
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Neutrophil count decreased
|
80.0%
48/60 • Number of events 419
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
76.5%
26/34 • Number of events 113
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
82.9%
29/35 • Number of events 132
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
85.7%
30/35 • Number of events 106
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
85.0%
51/60 • Number of events 304
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
82.4%
98/119 • Number of events 284
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
63.6%
21/33 • Number of events 90
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Platelet count decreased
|
51.7%
31/60 • Number of events 186
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
52.9%
18/34 • Number of events 87
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
85.7%
30/35 • Number of events 137
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
85.7%
30/35 • Number of events 74
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
71.7%
43/60 • Number of events 152
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
82.4%
98/119 • Number of events 262
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
57.6%
19/33 • Number of events 93
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Weight gain
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Investigations
Weight loss
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
20/60 • Number of events 44
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
47.1%
16/34 • Number of events 23
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
28.6%
10/35 • Number of events 22
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
34.3%
12/35 • Number of events 15
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
30.0%
18/60 • Number of events 50
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
38.7%
46/119 • Number of events 70
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
36.4%
12/33 • Number of events 37
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
23.3%
14/60 • Number of events 29
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
14.7%
5/34 • Number of events 19
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
26.7%
16/60 • Number of events 58
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.4%
10/119 • Number of events 14
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
4/60 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
4/60 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.3%
2/60 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 14
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis lower limb
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Ataxia
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.3%
5/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Neurological disorder NOS
|
3.3%
2/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
75.0%
45/60 • Number of events 664
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
67.6%
23/34 • Number of events 221
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
80.0%
28/35 • Number of events 233
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
88.6%
31/35 • Number of events 120
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
70.0%
42/60 • Number of events 349
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
79.0%
94/119 • Number of events 332
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
87.9%
29/33 • Number of events 259
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Syncope
|
8.3%
5/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
6.1%
2/33 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Taste alteration
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Nervous system disorders
Tremor
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Agitation
|
16.7%
10/60 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
11.4%
4/35 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Anxiety
|
10.0%
6/60 • Number of events 9
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.4%
4/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Confusion
|
11.7%
7/60 • Number of events 10
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.8%
3/34 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
9.1%
3/33 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Depression
|
10.0%
6/60 • Number of events 8
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 7
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Psychiatric disorders
Euphoria
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.9%
2/34 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.6%
3/35 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
8.3%
5/60 • Number of events 11
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.4%
4/119 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
21.2%
7/33 • Number of events 14
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
2/119 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Atrophy skin
|
1.7%
1/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.7%
1/60 • Number of events 6
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.7%
1/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
8.3%
5/60 • Number of events 12
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/34 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 17
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Hypertension
|
5.0%
3/60 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/60
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/119
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Hypotension
|
3.3%
2/60 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/35
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.84%
1/119 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/33
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
|
Vascular disorders
Thrombosis
|
1.7%
1/60 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
0.00%
0/34
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.7%
2/35 • Number of events 4
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.9%
1/35 • Number of events 2
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
5.0%
3/60 • Number of events 3
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
2.5%
3/119 • Number of events 5
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
3.0%
1/33 • Number of events 1
One participant in the Relapse/Refractory Myeloma: High Dose group refused prior to starting treatment, thus was not included in the adverse event analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place