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

ENROLLING
Protocol # :
23-291
Conditions
Multiple Myeloma
Phase
I/II
Disease Sites
Multiple Myeloma
Principal Investigator
Hartley-Brown, Monique

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. 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

23-291