Clinical Trial: Cancer, Multiple Myeloma

BMS CA057-001

Full Name

A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY COMPARING MEZIGDOMIDE (CC-92480), BORTEZOMIB AND DEXAMETHASONE (MEZIVd) VERSUS POMALIDOMIDE, BORTEZOMIB AND DEXAMETHASONE (PVd) IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM): SUCCESSOR-1

Description

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Eligibility

Inclusion Criteria

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

  1. M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.
  2. M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).
  3. 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, except as noted below:

  1. Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.
  2. Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.
    • 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 mezigdomide or pomalidomide.
    • Other protocol-defined Inclusion/Exclusion criteria apply.
Doctor(s) Running This Study

Specialties

  • Hematology/Medical Oncology

Area of focus i

  • Hematologic Malignancy (Leukemia/Lymphoma/Myeloma)
  • Bleeding Disorders
  • Melanoma/Immunotherapy

Affiliated with

LVPG Cliniciani

Accepting New Patients