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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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).

🚫 You may not be able to join if…

• 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

Where this trial is running

• UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
• Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
• Dana-Farber Cancer Institute, Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center, New York, New York, United States
• Alberta Health Services AHS - Foothills Medical Centre FMC, Calgary, Alberta, Canada
• University of Alberta - Cross Cancer Institute, Edmonton, Alberta, Canada
• University Health Network UHN - Princess Margaret Hospital PMH, Toronto, Ontario, Canada
• Oslo University Hospital, Oslo, Outside US and Canada, Norway
• ICO - Hospital Germans Trias i Pujol, Barcelona, Spain
• Hospital Universitario 12 de Octubre, Madrid, Spain
• Hospital Universitario Marques de Valdecilla, Santander, Spain

+ 5 more sites.

Who to contact

BMS Study Connect Contact Center www.BMSStudyConnect.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05372354.