drugset / Trial / NCT05669989
International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
NaSingle-groupOpen-labelTreatment
Summary
* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.
Timeline
- Start
- 2023-04-05
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | — | Intravenous |
| Background | Carfilzomib | Other / unclassified | — | Intravenous |
| Background | Cemiplimab | Monoclonal antibody | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Lenalidomide | Other / unclassified | — | Oral |
| Background | Pomalidomide | Other / unclassified | — | Oral |