Trials / Active Not Recruiting
Active Not RecruitingNCT03651128
Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 381 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | bb2121 | bb2121 |
| DRUG | Daratumumab | Daratumumab |
| DRUG | Pomalidomide | Pomalidomide |
| DRUG | Dexamethasone | Dexamethasone |
| DRUG | Bortezomib | Bortezomib |
| DRUG | Ixazomib | Ixazomib |
| DRUG | Lenalidomide | Lenalidomide |
| DRUG | Carfilzomib | Carfilzomib |
| DRUG | Elotuzumab | Elotuzumab |
Timeline
- Start date
- 2019-04-16
- Primary completion
- 2027-04-08
- Completion
- 2027-04-08
- First posted
- 2018-08-29
- Last updated
- 2022-12-15
Locations
60 sites across 13 countries: United States, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03651128. Inclusion in this directory is not an endorsement.