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

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

Trial Details

NCT ID
NCT07479979
Phase
PHASE1 / PHASE2
Sponsor
Natalie Callander
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Selinexor
  • Carfilzomib
  • Isatuximab
  • Isatuximab SC Wearable Injection System
  • Dexamethasone
Locations (sample)
  • Madison, Wisconsin, United States|43.07305,-89.40123

Key Eligibility Criteria

  • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the infor…
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \>2 will be allowed only if it is related to bone pain …
  • Patients with a diagnosis of relapsed or relapsed/refractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we wi…

For full eligibility, visit ClinicalTrials.gov.

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