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
Trial 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).
Eligibility Requirements
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