drugset / Trial / NCT04287855
Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
Phase 2
Unknown
82 enrolled
Poitiers University Hospital
Amgen · collabCelgene Corporation · collabIntergroupe Francophone du Myelome · collabSanofi · collab
NaSingle-groupOpen-labelTreatment
Summary
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase
Timeline
- Start
- 2020-08-28
- Primary completion
- 2025-04-15
- Completion
- 2026-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 56 mg/m2 | Oral |
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |