drugset / Trial / NCT05911321
Isa-Pom-Dex in Elderly/Frail Subjects With RRMM
Phase 2
Active not recruiting
6 enrolled
UNC Lineberger Comprehensive Cancer Center
Genzyme, a Sanofi Company · collab
NaSingle-groupOpen-labelTreatment
Summary
This research study aims to evaluate the safety and effectiveness of the combination of isatuximab, pomalidomide, and dexamethasone (Isa-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM), which refers to multiple myeloma that has returned or has not responded to prior treatment. The study will specifically investigate the impact of administering lower-than-standard doses of pomalidomide and dexamethasone. Using lower doses of pomalidomide and dexamethasone in this setting has not been approved by the Food and Drug Administration (FDA).
Timeline
- Start
- 2023-12-05
- Primary completion
- 2025-06-18
- Completion
- 2028-03-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Isatuximab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Pomalidomide | Other / unclassified | 3 mg | Oral |