Brief Summary:
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in
combination with standard treatments.
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
Primary outcome:
1. Recommended Dose (Time Frame - Up to approximately 3 years)
2. Recommended regimen as measured by dose-limiting toxicities (Time Frame - Up to approximately 3 years)
3. Number of participants with Adverse Events (AEs) (Time Frame - From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years)
4. Overall response rate (ORR) (Time Frame - Up to approximately 5 years)
Secondary outcome:
1. Time-to-response (TTR) (Time Frame - Up to approximately 5 years)
2. Duration of response (DOR) (Time Frame - Up to approximately 5 years)
3. Complete Response (CR) rate (Time Frame - Up to approximately 5 years)
4. Very good partial response (VGPR) rate - Cohorts D and E (Time Frame - Up to approximately 5 years)
- Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
- Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
- Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
- Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
- Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
- Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
- Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
- Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
- Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
- Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
- Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
- Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
- Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
- Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
- Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone
- CC-92480 (BMS-986348 / mezigdomide / ):
Specified dose on specified days - Bortezomib:
Specified dose on specified days - Dexamethasone:
Specified dose on specified days - Daratumumab:
Specified dose on specified days - Carfilzomib:
Specified dose on specified days - Elotuzumab:
Specified dose on specified days - Isatuximab:
Specified dose on specified days - Carfilzomib:
Specified dose on specified days
Quelle: ClinicalTrials.gov