Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma
Summary
Isatuximab targets and kills CD38-positive myeloma cells in manner similar to rituximab's mechanism of action on CD20-positive lymphoma cells. Based on the synergy between rituximab and bendamustine, as well as the established clinical efficacy of bendamustine and isatuximab as single agents for multiple myeloma, the logical next step is to combine isatuximab with bendamustine and prednisone. Due to lack of effective therapies in refractory multiple myeloma, herein the investigators propose studying this novel combination in this population, in order to address a significant unmet need. The aim of the investigators is to first determine the maximal tolerated dose of the combination in participants with relapsed/refractory myeloma and then to establish the efficacy of this novel combination.
Timeline
- Start
- 2020-04-03
- Primary completion
- 2023-03-13
- Completion
- 2024-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 50 mg/m2 | — |
| Subject | Bendamustine | Small molecule | 75 mg/m2 | — |
| Subject | Bendamustine | Small molecule | 100 mg/m2 | — |
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Prednisone | Other / unclassified | 60 mg | — |