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Taking peoplePhase 1/2

Tests CC-92480 combinations in adults with relapsed or refractory multiple myeloma

Tests CC-92480 with other drugs in adults with returning or resistant multiple myeloma.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Oslo, NorwaySee the site
Phase
Phase 1/2

Where in Norway

  • Oslo University Hospital HFOslo, NorwayNo longer taking part

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Trial details

Who runs it
Bristol-Myers Squibb
Trial code
NCT05372354EU 2023-509384-25-00
Record updated
5 September 2025
Original description
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).Read full original descriptionShow less

An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma

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).

Inclusion: Relapsed or refractory multiple myeloma (MM) and must:; Have documented disease progression during or after their last myeloma therapy; 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: 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:; Plasmapheresis; Major surgery; Radiation therapy other than local therapy for myeloma associated bone lesions; 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; 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.

ClinicalTrials.gov NCT05372354 · EU CTIS 2023-509384-25-00