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
Multiple MyelomaThe 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).
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
University Health Network UHN - Princess Margaret Hospital PMH
University Health Network UHN - Princess Margaret Hospital PMHToronto, Ontario
Canada
Contactez l'équipe d'étude
Donna Reece, Site 0004
4169462824Alberta Health Services AHS - Foothills Medical Centre FMC
Alberta Health Services AHS - Foothills Medical Centre FMCCalgary, Alberta
Canada
Contactez l'équipe d'étude
Nizar Bahlis, Site 0009
14039441880University of Alberta - Cross Cancer Institute
University of Alberta - Cross Cancer InstituteEdmonton, Alberta
Canada
Contactez l'équipe d'étude
Michael Chu, Site 0008
7804328757- Étude parrainée par
- Bristol-Myers Squibb
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05372354