Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
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.
Timeline
- Start
- 2019-04-16
- Primary completion
- 2026-04-13
- Completion
- 2026-04-13
Outcome
Met primary endpoint
paper the median progression-free survival was 13.3 months in the ide-cel group, as compared with 4.4 months in the standard-regimen group PMID 36762851 ↗
paper Ide-cel therapy significantly prolonged progression-free survival and improved response as compared with standard regimens PMID 36762851 ↗
release “The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard regimens” bms.com ↗
Publications
- Lopez-Munoz N, Bar N, Diels J, van Sanden S, Mendes J, Lee S, Hernando T, Lendvai N, Patel N, Ishida T, Er J, Harrison SJ. Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison. Adv Ther. 2026 Mar;43(3):1327-1340. doi: 10.1007/s12325-025-03479-y. Epub 2026 Feb 2.
- Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon S, Abrahamsen IW, Baz R, Broijl A, Chen C, Jagannath S, Raje N, Scheid C, Delforge M, Benjamin R, Pabst T, Iida S, Berdeja J, Giralt S, Truppel-Hartmann A, Chen Y, Zhong X, Wu F, Piasecki J, Eliason L, Dhanda D, Felten J, Caia A, Cook M, Popa McKiver M, Rodriguez-Otero P. Ide-cel vs standard regimens in triple-class-exposed relapsed and refractory multiple myeloma: updated KarMMa-3 analyses. Blood. 2024 Dec 5;144(23):2389-2401. doi: 10.1182/blood.2024024582.
- Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Plain language summary of the KarMMa-3 study of ide-cel or standard of care regimens in people with relapsed or refractory multiple myeloma. Future Oncol. 2024;20(18):1221-1235. doi: 10.2217/fon-2023-0954. Epub 2024 Apr 23.
- Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014. doi: 10.1056/NEJMoa2213614. Epub 2023 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | — |
| Subject | Carfilzomib | Other / unclassified | — | — |
| Subject | Daratumumab | Monoclonal antibody | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Elotuzumab | Monoclonal antibody | — | — |
| Subject | Ixazomib | Unknown | — | — |
| Subject | Lenalidomide | Other / unclassified | — | — |
| Subject | Pomalidomide | Other / unclassified | — | — |
| Subject | idecabtagene vicleucel | Cell therapy | 1.5e+08 cells | — |
| Subject | idecabtagene vicleucel | Cell therapy | 4.5e+08 cells | — |