drugset / Trial / NCT04643002
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.
Timeline
- Start
- 2021-01-25
- Primary completion
- 2027-09-13
- Completion
- 2028-04-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | — | Intravenous |
| Subject | Belumosudil | Small molecule | — | Oral |
| Subject | Evorpacept | Protein / enzyme biologic | — | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | — | Intravenous |
| Subject | Pegenzileukin | Protein / enzyme biologic | — | Intravenous |
| Comparator | Pomalidomide | Other / unclassified | — | Oral |
| Subject | SAR439459 | Monoclonal antibody | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |