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)
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Celgene
- Study ID
- NCT03989414
- Phase
- PHASE1/PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CC-92480 — DRUGSpecified dose on specified days
- Bortezomib — DRUGSpecified dose on specified days
- Dexamethasone — DRUGSpecified dose on specified days
- Daratumumab — DRUGSpecified dose on specified days
- Carfilzomib — DRUGSpecified dose on specified days
- Elotuzumab — DRUGSpecified dose on specified days
- Isatuximab — DRUGSpecified dose on specified days
- Carfilzomib — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Key Dates
- Start date
- Sep 30, 2019
- Status verified
- Oct 2024
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
Study Design
- Enrollment
- 424 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- 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
Primary Outcome Measure
Recommended Dose [ Time Frame: Up to approximately 3 years ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 119 | Denver | Colorado | 80218 | - |
| Local Institution - 104 | Tampa | Florida | 33612 | - |
| Local Institution - 108 | Atlanta | Georgia | 30322 | - |
| Local Institution - 107 | Chicago | Illinois | 60637 | - |
| Local Institution - 112 | Chicago | Illinois | 60611 | - |
| Local Institution - 101 | Boston | Massachusetts | 02115 | - |
| Local Institution - 117 | Boston | Massachusetts | 02114 | - |
| Local Institution - 118 | Boston | Massachusetts | 02215 | - |
| Local Institution - 113 | Detroit | Michigan | 48201 | - |
| Local Institution - 106 | Rochester | Minnesota | 55905 | - |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | - |
| Local Institution - 110 | Winston-Salem | North Carolina | 27157 | - |
| Local Institution - 115 | Columbus | Ohio | 43210 | - |
| Local Institution - 114 | Nashville | Tennessee | 37203 | - |
| Local Institution - 116 | Houston | Texas | 77030 | - |
| Swedish Cancer Institute | Seattle | Washington | 98104 | - |
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