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Recruiting

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma - CA057-003

Updated: 29 September, 2023   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 12

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1 Arm A: Dose Finding
Drug: Dexamethasone, CC-92480, Tazemetostat
Experimental: Part 1 Arm B: Dose Finding
Drug: CC-92480, BMS-986158, Dexamethasone
Experimental: Part 1 Arm C: Dose Finding
Drug: Dexamethasone, CC-92480, Trametinib
Active Comparator: Part 2 Arm D: Dose Expansion
Drug: Dexamethasone, CC-92480
Experimental: Part 2 Arm E: Dose Expansion
Drug: CC-92480, Dexamethasone, Tazemetostat
Experimental: Part 2 Arm F: Dose Expansion
Drug: CC-92480, Dexamethasone, BMS-986158
Experimental: Part 2 Arm G: Dose Expansion
Drug: CC-92480, Dexamethasone, Trametinib

Key Eligibility Criteria

Inclusion Criteria: - Relapsed or refractory multiple myeloma (MM) and must: 1. have documented disease progression during or after their last myeloma therapy 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM - Must have measurable disease - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 - Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP) Exclusion Criteria: - Known active or history of central nervous system (CNS) involvement of MM - Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis. - Impaired cardiac function or clinically significant cardiac disease - Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1) - For Part 1: received prior therapy with CC-92480 - For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib - Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment - Received any of the following within 14 days prior to initiating study treatment: 1. Plasmapheresis 2. Major surgery 3. Radiation therapy other than local therapy for myeloma associated bone lesions 4. Use of any systemic anti-myeloma drug therapy - Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment - COVID-19 vaccine within 14 days prior to C1D1 Other protocol-defined inclusion/exclusion criteria apply

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