drugset / Trial / NCT07479979
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
Phase 1/2
Recruiting
62 enrolled
Natalie Callander
Karyopharm Therapeutics Inc · collabSanofi · collabUniversity of Wisconsin, Madison · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.
Timeline
- Start
- 2026-07
- Primary completion
- 2027-07
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Isatuximab | Monoclonal antibody | 1400 mg | Other |
| Subject | Selinexor | Other / unclassified | 20 mg | Oral |
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |