drugset / Trial / NCT04126200
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
RandomizedSequentialOpen-labelTreatment
Summary
B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.
Timeline
- Start
- 2019-10-07
- Primary completion
- 2025-04-17
- Completion
- 2027-03-11
Publications
- Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17.
- Nooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Dostarlimab | Monoclonal antibody | — | — |
| Subject | Feladilimab | Monoclonal antibody | — | — |
| Subject | GSK3174998 | Monoclonal antibody | — | — |
| Subject | Isatuximab | Monoclonal antibody | — | — |
| Subject | Lenalidomide | Other / unclassified | — | — |
| Subject | Nirogacestat | Small molecule | — | — |
| Subject | Pomalidomide | Other / unclassified | — | — |