Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
Summary
Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of three treatment selection groups. The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. Selection groups are as follows: Group 1: Selinexor + pomalidomide + dexamethasone (SPd) Group 2: Selinexor + daratumumab + dexamethasone (SDd) Group 3: Selinexor + carfilzomib + dexamethasone (SKd)
Timeline
- Start
- 2021-11-18
- Primary completion
- 2024-08-06
- Completion
- 2026-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Subject | Daratumumab | Monoclonal antibody | 30000 iu | Subcutaneous |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |
| Subject | Selinexor | Other / unclassified | 80 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |