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

• Status: Not yet recruiting
• Trial end date: 2025-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dexamethasone; Trametinib

Criteria

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