Phase 3 Clinical Trial Evaluating the Safety and Effectiveness of Investigational Drug Mezigdomide in Combination with Bortezomib and Dexamethasone Compared to Pomalidomide, Bortezomib 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 given in combination with approved treatments Bortezomib and Dexamethasone. Researchers will compare this investigational combination against standard of care treatments Pomalidomide, Bortezomib and Dexamethasone to learn more about how Mezigdomide works in relapsed or refractory multiple myeloma. 

SparkCures ID 1317
Trial Phase Phase 3
Enrollment 810 Patients
Treatments
Tags
Trial Sponsors
  • Celgene Corporation, a wholly owned subsidiary of Bristol Myers Squibb
NCT Identifier

NCT05519085

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 MM and measurable disease, defined as any of the following:

    • M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or
    • M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP)
    • For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Exclusion Criteria:

  • Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor.
  • For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
  • Participant has had prior treatment with CC-92480 or pomalidomide.

Other protocol-defined criteria apply.

US Trial Locations

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Trial Links

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