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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllBristol-Myers Squibb
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Relapsed or refractory multiple myeloma (MM) and must: 1. Have documented disease progression during or after their last myeloma therapy. 2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT. * 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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What it tests

  • CC-92480
  • Tazemetostat
  • BMS-986158
  • Trametinib
  • Dexamethasone
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Where

17 sites
UAB Comprehensive Cancer Center
Birmingham, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, United States
Dana-Farber Cancer Institute
Boston, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Canada
University of Alberta - Cross Cancer Institute
Edmonton, Canada
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Canada

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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