Trial Outcomes & Findings for Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (NCT NCT04126200)
NCT ID: NCT04126200
Last Updated: 2026-05-06
Results Overview
Number of Participants who passed screening and were randomized across sub studies are presented.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
208 participants
Day 1
2026-05-06
Participant Flow
This master record includes data of screened participants for its sub-studies, 208887 Substudy 1 (NCT06160609), Substudy 2 (NCT07217119), Substudy 3 (NCT07084896), Substudy 4 (NCT06655818), Substudy 5 (NCT07217184), Substudy 6 (NCT07150091), Substudy 7 (NCT07150104) and only contains data collected during screening phase (Day -30 to Day 0). Results are presented separately for each sub study.
A total of 271 participants started the overall study which includes all participants who were screened for eligibility prior to enrollment. 208 participants met eligibility criteria and were randomized in the sub-studies.
Participant milestones
| Measure |
All Screened Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) were screened to be randomized in sub-studies of this master protocol.
|
|---|---|
|
Overall Study
STARTED
|
271
|
|
Overall Study
COMPLETED
|
208
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
All Screened Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) were screened to be randomized in sub-studies of this master protocol.
|
|---|---|
|
Overall Study
Screen Failed
|
62
|
|
Overall Study
Completed screening but not randomized to sub study
|
1
|
Baseline Characteristics
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Baseline characteristics by cohort
| Measure |
All Screened Participants
n=271 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) were screened to be randomized in sub-studies of this master protocol.
|
|---|---|
|
Age, Continuous
|
67.1 YEARS
STANDARD_DEVIATION 8.89 • n=54 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Asian
|
46 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
White
|
209 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
12 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: All participants who passed screening and were randomized.
Number of Participants who passed screening and were randomized across sub studies are presented.
Outcome measures
| Measure |
All Screened Participants
n=208 Participants
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) were screened to be randomized in sub-studies of this master protocol.
|
|---|---|
|
Number of Participants Randomized Across Sub-studies
Substudy 2
|
25 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 3
|
106 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 1
|
9 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 4
|
4 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 5
|
30 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 6
|
20 Participants
|
|
Number of Participants Randomized Across Sub-studies
Substudy 7
|
14 Participants
|
Adverse Events
All Screened Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER