A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
- Interventional
- Recruiting
- NCT03989414
Contact Information
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
Inclusion Criteria:
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Exclusion Criteria:
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Other protocol-defined inclusion/exclusion criteria apply
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Exclusion Criteria:
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Other protocol-defined inclusion/exclusion criteria apply