drugset / Trial / NCT05028348
A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma
Phase 3
Active not recruiting
117 enrolled
European Myeloma Network B.V.
Karyopharm Therapeutics Inc · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).
Timeline
- Start
- 2022-04-19
- Primary completion
- 2026-03
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Elotuzumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Pomalidomide | Other / unclassified | 4 mg | Oral |