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Hledat Study Connect

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: 8 srpen, 2024   |   ClinicalTrials.gov

Tisk přehledného shrnutí

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Podrobnosti o hodnocení

  • Phase 1/Phase 2

    Fáze

  • Pohlaví

  • 18+

    Věková skupina

  • 12

    Umístění

  • Recruiting

Možnosti léčby

Ramena studie
Přiřazená léčba
Experimental: Part 1 Arm A: Dose Finding
Drug: CC-92480, Dexamethasone, Tazemetostat
Experimental: Part 1 Arm B: Dose Finding
Drug: CC-92480, BMS-986158, Dexamethasone
Experimental: Part 1 Arm C: Dose Finding
Drug: CC-92480, Dexamethasone, 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

Klíčová kritéria způsobilosti

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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