Study Comparing Mezigdomide with Carfilzomib and Dexamethasone to Carfilzomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT05552976

This clinical trial is testing a new combination of drugs, Mezigdomide with Carfilzomib and Dexamethasone, against the standard treatment of Carfilzomib and Dexamethasone alone, to see which is more effective for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The goal of this study is to find out if adding Mezigdomide to the standard treatment of Carfilzomib and Dexamethasone can better help patients with relapsed or refractory multiple myeloma, a type of blood cancer, compared to using Carfilzomib and Dexamethasone alone.

Eligibility Criteria

Inclusion Criteria

  • Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.

i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.

ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.

  • Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy).
  • Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible).
  • Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
  • Participant must have documented disease progression during or after their last antimyeloma regimen.

Exclusion Criteria

  • Participant who has had prior treatment with mezigdomide or carfilzomib.
  • Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

FACILITYZIPCITYSTATE
USA Mitchell Cancer Institute36604MobileAlabama
TOI Clinical Research90703CerritosCalifornia
Kaiser Permanente - Irvine92618IrvineCalifornia
Los Angeles Hematology Oncology Medical Group90017Los AngelesCalifornia
Local Institution - 034495403Santa RosaCalifornia
Stockton Hematology Oncology Group95204StocktonCalifornia
Local Institution - 027919713NewarkDelaware
Local Institution - 034133901Fort MyersFlorida
Local Institution - 034233705Saint PetersburgFlorida
Local Institution - 034033401West Palm BeachFlorida

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