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)
Trial Description
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480
in combination with standard treatments.
Eligibility Requirements
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