drugset / Trial / NCT05066607
Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy
Phase 2
Unknown
46 enrolled
Intergroupe Francophone du Myelome
Bristol-Myers Squibb · collabSanofi · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase 2 study ain to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy. It will enrolled 46 patients (34 in France and 12 in Australia) through 15 sites (11 in France and 4 in Australia).
Timeline
- Start
- 2022-02-11
- Primary completion
- 2026-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Dexamethasone | Small molecule | 10 mg | — |
| Background | Dexamethasone | Small molecule | 20 mg | — |
| Background | Pomalidomide | Other / unclassified | 4 mg | Oral |