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)
Phase 1
Active, not recruiting
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT03989414
- Lead Sponsor
- Celgene
- Brief Summary
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 424
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C: CC-92480 with carfilzomib and dexamethasone CC-92480 - Cohort C: CC-92480 with carfilzomib and dexamethasone Dexamethasone - Cohort H: CC-92480 with elotuzumab and dexamethasone CC-92480 - Cohort I: CC-92480 with isatuximab and dexamethasone Dexamethasone - Cohort I: CC-92480 with isatuximab and dexamethasone Isatuximab - Cohort F: CC-92480 with carfilzomib and dexamethasone Dexamethasone - Subcohort E3: CC-92480 with daratumumab and dexamethasone CC-92480 - Cohort C: CC-92480 with carfilzomib and dexamethasone Carfilzomib - Cohort I: CC-92480 with isatuximab and dexamethasone CC-92480 - Cohort K: CC-92480 with isatuximab and dexamethasone CC-92480 - Cohort A: CC-92480 with bortezomib and dexamethasone CC-92480 - Cohort H: CC-92480 with elotuzumab and dexamethasone Elotuzumab - Cohort F: CC-92480 with carfilzomib and dexamethasone CC-92480 - Subcohort B1: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort B2: CC-92480 with daratumumab and dexamethasone CC-92480 - Subcohort E1: CC-92480 with daratumumab and dexamethasone CC-92480 - Subcohort B1: CC-92480 with daratumumab and dexamethasone CC-92480 - Cohort G: CC-92480 with bortezomib and dexamethasone CC-92480 - Subcohort B3: CC-92480 with daratumumab and dexamethasone CC-92480 - Cohort J: CC-92480 with elotuzumab and dexamethasone CC-92480 - Cohort D: CC-92480 with bortezomib and dexamethasone CC-92480 - Subcohort E2: CC-92480 with daratumumab and dexamethasone CC-92480 - Cohort D: CC-92480 with bortezomib and dexamethasone Dexamethasone - Cohort A: CC-92480 with bortezomib and dexamethasone Dexamethasone - Cohort A: CC-92480 with bortezomib and dexamethasone Bortezomib - Cohort H: CC-92480 with elotuzumab and dexamethasone Dexamethasone - Cohort D: CC-92480 with bortezomib and dexamethasone Bortezomib - Cohort J: CC-92480 with elotuzumab and dexamethasone Elotuzumab - Cohort F: CC-92480 with carfilzomib and dexamethasone Carfilzomib - Cohort J: CC-92480 with elotuzumab and dexamethasone Dexamethasone - Cohort K: CC-92480 with isatuximab and dexamethasone Dexamethasone - Cohort K: CC-92480 with isatuximab and dexamethasone Isatuximab - Cohort G: CC-92480 with bortezomib and dexamethasone Bortezomib - Cohort G: CC-92480 with bortezomib and dexamethasone Dexamethasone - Subcohort B1: CC-92480 with daratumumab and dexamethasone Daratumumab - Subcohort B2: CC-92480 with daratumumab and dexamethasone Daratumumab - Subcohort B2: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort B3: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort B3: CC-92480 with daratumumab and dexamethasone Daratumumab - Subcohort E1: CC-92480 with daratumumab and dexamethasone Daratumumab - Subcohort E1: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort E2: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort E2: CC-92480 with daratumumab and dexamethasone Daratumumab - Subcohort E3: CC-92480 with daratumumab and dexamethasone Dexamethasone - Subcohort E3: CC-92480 with daratumumab and dexamethasone Daratumumab -
- Primary Outcome Measures
Name Time Method Recommended Dose Up to approximately 3 years Recommended regimen as measured by dose-limiting toxicities Up to approximately 3 years Number of participants with Adverse Events (AEs) From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years Overall response rate (ORR) Up to approximately 5 years
- Secondary Outcome Measures
Name Time Method Complete Response (CR) rate Up to approximately 5 years Very good partial response (VGPR) rate - Cohorts D and E Up to approximately 5 years Time-to-response (TTR) Up to approximately 5 years Duration of response (DOR) Up to approximately 5 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does CC-92480 target in multiple myeloma treatment?
How does CC-92480 combination therapy compare to standard-of-care regimens in relapsed or refractory multiple myeloma?
Which biomarkers are associated with response to CC-92480 in newly diagnosed multiple myeloma patients?
What are the potential adverse events of CC-92480 in combination with dexamethasone, bortezomib, and carfilzomib?
How does CC-92480's efficacy in multiple myeloma compare to other BTK inhibitors like ibrutinib or zanubrutinib?
Trial Locations
- Locations (49)
Local Institution - 119
🇺🇸Denver, Colorado, United States
Local Institution - 104
🇺🇸Tampa, Florida, United States
Local Institution - 108
🇺🇸Atlanta, Georgia, United States
Local Institution - 112
🇺🇸Chicago, Illinois, United States
Local Institution - 107
🇺🇸Chicago, Illinois, United States
Local Institution - 117
🇺🇸Boston, Massachusetts, United States
Local Institution - 101
🇺🇸Boston, Massachusetts, United States
Local Institution - 118
🇺🇸Boston, Massachusetts, United States
Local Institution - 113
🇺🇸Detroit, Michigan, United States
Local Institution - 106
🇺🇸Rochester, Minnesota, United States
Scroll for more (39 remaining)Local Institution - 119🇺🇸Denver, Colorado, United States