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
Recruiting now · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
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).
Key facts
- Study ID
- NCT05372354
- Run by
- Bristol-Myers Squibb
- People needed
- 260
- Starts
- 2022-10-18
- Expected to finish
- 2026-10-12
- Last updated by the study team
- 2025-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- NIHR UCLH Clinical Research Facility — London, United Kingdom (enrolling)
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Alberta Health Services AHS - Foothills Medical Centre FMC — Calgary, Alberta, Canada (enrolling)
- University of Alberta - Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
- University Health Network UHN - Princess Margaret Hospital PMH — Toronto, Ontario, Canada (enrolling)
- Oslo University Hospital — Oslo, Outside US and Canada, Norway (enrolling)
- ICO - Hospital Germans Trias i Pujol — Barcelona, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Hospital Universitario Marques de Valdecilla — Santander, Spain (enrolling)
- The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (enrolling)
- Churchill Hospital — Oxford, Oxfordshire, United Kingdom (enrolling)
- UAB Comprehensive Cancer Center — Birmingham, Alabama, United States (enrolling)
- Local Institution - 0001 — Leicester, Leicestershire, United Kingdom
- Local Institution - 0014 — Liverpool, Merseyside, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.