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NCT03601078 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 312
- Enrollment target
NCT03601078: Completed Phase 2 study, sponsored by Celgene.
NCT03601078 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 312 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03601078, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 312 participants
- Enrollment target
Study Summary
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 248 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.
Primary Outcome
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Interventions
- DRUG Talquetamab
- BIOLOGICAL bb2121
- DRUG Lenalomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 2 |
What the finished NCT03601078 record still lists
NCT03601078 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher).
The record links to 0 conditions, and to 3 interventions - of which Talquetamab is the first listed.
NCT03601078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03601078 about?
NCT03601078 is a clinical study titled "An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma". This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with...
What is the current status of trial NCT03601078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2018-12-13. Estimated completion is 2026-01-15.
What interventions are being tested in trial NCT03601078?
The interventions under investigation include: Talquetamab (DRUG), bb2121 (BIOLOGICAL), Lenalomide (DRUG).
Who is sponsoring clinical trial NCT03601078?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03601078's enrollment target sits among peer trials
312 161st of 2000 higher than 1,839 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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