Overview
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).
Eligibility
Inclusion Criteria:
- Relapsed or refractory multiple myeloma (MM) and must:
- have documented disease progression during or after their last myeloma therapy
- 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:
- 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