Phase 3 Study Evaluating the Safety and Effectiveness of Investigational Drug Mezigdomide in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma

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Overview

The goal of this clinical trial is to learn more about the safety and effectiveness of investigational drug Mezigdomide when combined with approved treatments carfilzomib and dexamethasone compared to approved treatments carfilzomib and dexamethasone alone in participants with relapsed and refractory multiple myeloma. 

SparkCures ID 1320
Trial Phase Phase 3
Enrollment 606 Patients
Treatments
Tags
Trial Sponsors
  • Bristol Myers Squibb
NCT Identifier

NCT05552976

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:
    • Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or
    • M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,
    • 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 an anti-CD38 monoclonal antibody.
  • 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 CC-92480 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.

Additional protocol-defined criteria apply.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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