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NCT03651128 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
A Phase 3 study of Multiple Myeloma, sponsored by Celgene.
- Active
- Registry status
- Phase 3
- Development phase
- 381
- Enrollment target
- 20
- Study locations
NCT03651128: Active Phase 3 study of Multiple Myeloma, sponsored by Celgene.
NCT03651128 is a Phase 3 study of Multiple Myeloma that is active but no longer recruiting, run by Celgene. The registered enrollment target is 381 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651128, a Phase 3 study of Multiple Myeloma, is active but no longer recruiting, sponsored by Celgene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 381 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.
Primary Outcome
Time from randomization to the first documentation of progressive disease based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma assessed by an independent response committee (IRC) or death due to any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Pomalidomide
- DRUG Bortezomib
- BIOLOGICAL bb2121
Study Locations (20)
California
- Local Institution - 145 - Los Angeles
- Local Institution - 122 - Los Angeles
- Local Institution - 124 - Palo Alto
Florida
- Local Institution - 108 - Jacksonville
- Local Institution - 102 - Tampa
Georgia
- Local Institution - 131 - Atlanta
- Local Institution - 140 - Atlanta
Massachusetts
- Local Institution - 134 - Boston
- Local Institution - 123 - Boston
Alabama
- Local Institution - 109 - Birmingham
Arizona
- Local Institution - 141 - Scottsdale
Colorado
- Local Institution - 142 - Aurora
Illinois
- Local Institution - 139 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2027-04-08 |
| Phase | Phase 3 |
What the registry record for NCT03651128 still lists
NCT03651128 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03651128 names 20 study sites across 15 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03651128 about?
NCT03651128 is a clinical study titled "Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)". This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects ...
What is the current status of trial NCT03651128?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2019-04-16. Estimated completion is 2027-04-08.
What conditions does trial NCT03651128 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT03651128?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG), Bortezomib (DRUG), bb2121 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03651128?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03651128 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03651128's enrollment target sits among peer trials
381 62nd of 438 higher than 377 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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