Multiple Myeloma Clinical Trial
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
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).
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory multiple myeloma (MM) and must:
have documented disease progression during or after their last myeloma therapy
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:
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
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There are 15 Locations for this study
Baltimore Maryland, 21287, United States More Info
Manchester Greater Manchester, M20 4, United Kingdom More Info
Contact
Liverpool Merseyside, L7 8Y, United Kingdom
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