Clinical Trial

Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma

Recruiting Phase 1/2
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-15
Trial Details
NCT Number NCT07479979
Lead Sponsor Natalie Callander
Collaborators: Sanofi, Karyopharm Therapeutics Inc, University of Wisconsin, Madison
Conditions Relapse Multiple Myeloma, Refractory Multiple Myeloma
Enrollment 62 participants
Start Date 2026-07
Primary Completion 2027-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-14