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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)

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
GroupInterventionDescription
Cohort C: CC-92480 with carfilzomib and dexamethasoneCC-92480-
Cohort C: CC-92480 with carfilzomib and dexamethasoneDexamethasone-
Cohort H: CC-92480 with elotuzumab and dexamethasoneCC-92480-
Cohort I: CC-92480 with isatuximab and dexamethasoneDexamethasone-
Cohort I: CC-92480 with isatuximab and dexamethasoneIsatuximab-
Cohort F: CC-92480 with carfilzomib and dexamethasoneDexamethasone-
Subcohort E3: CC-92480 with daratumumab and dexamethasoneCC-92480-
Cohort C: CC-92480 with carfilzomib and dexamethasoneCarfilzomib-
Cohort I: CC-92480 with isatuximab and dexamethasoneCC-92480-
Cohort K: CC-92480 with isatuximab and dexamethasoneCC-92480-
Cohort A: CC-92480 with bortezomib and dexamethasoneCC-92480-
Cohort H: CC-92480 with elotuzumab and dexamethasoneElotuzumab-
Cohort F: CC-92480 with carfilzomib and dexamethasoneCC-92480-
Subcohort B1: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort B2: CC-92480 with daratumumab and dexamethasoneCC-92480-
Subcohort E1: CC-92480 with daratumumab and dexamethasoneCC-92480-
Subcohort B1: CC-92480 with daratumumab and dexamethasoneCC-92480-
Cohort G: CC-92480 with bortezomib and dexamethasoneCC-92480-
Subcohort B3: CC-92480 with daratumumab and dexamethasoneCC-92480-
Cohort J: CC-92480 with elotuzumab and dexamethasoneCC-92480-
Cohort D: CC-92480 with bortezomib and dexamethasoneCC-92480-
Subcohort E2: CC-92480 with daratumumab and dexamethasoneCC-92480-
Cohort D: CC-92480 with bortezomib and dexamethasoneDexamethasone-
Cohort A: CC-92480 with bortezomib and dexamethasoneDexamethasone-
Cohort A: CC-92480 with bortezomib and dexamethasoneBortezomib-
Cohort H: CC-92480 with elotuzumab and dexamethasoneDexamethasone-
Cohort D: CC-92480 with bortezomib and dexamethasoneBortezomib-
Cohort J: CC-92480 with elotuzumab and dexamethasoneElotuzumab-
Cohort F: CC-92480 with carfilzomib and dexamethasoneCarfilzomib-
Cohort J: CC-92480 with elotuzumab and dexamethasoneDexamethasone-
Cohort K: CC-92480 with isatuximab and dexamethasoneDexamethasone-
Cohort K: CC-92480 with isatuximab and dexamethasoneIsatuximab-
Cohort G: CC-92480 with bortezomib and dexamethasoneBortezomib-
Cohort G: CC-92480 with bortezomib and dexamethasoneDexamethasone-
Subcohort B1: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Subcohort B2: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Subcohort B2: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort B3: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort B3: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Subcohort E1: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Subcohort E1: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort E2: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort E2: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Subcohort E3: CC-92480 with daratumumab and dexamethasoneDexamethasone-
Subcohort E3: CC-92480 with daratumumab and dexamethasoneDaratumumab-
Primary Outcome Measures
NameTimeMethod
Recommended DoseUp to approximately 3 years
Recommended regimen as measured by dose-limiting toxicitiesUp 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
NameTimeMethod
Complete Response (CR) rateUp to approximately 5 years
Very good partial response (VGPR) rate - Cohorts D and EUp to approximately 5 years
Time-to-response (TTR)Up to approximately 5 years
Duration of response (DOR)Up to approximately 5 years

Trial Locations

Locations (49)

Local Institution - 119

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Denver, Colorado, United States

Local Institution - 104

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Tampa, Florida, United States

Local Institution - 108

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Atlanta, Georgia, United States

Local Institution - 112

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Chicago, Illinois, United States

Local Institution - 107

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Chicago, Illinois, United States

Local Institution - 117

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Boston, Massachusetts, United States

Local Institution - 101

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Boston, Massachusetts, United States

Local Institution - 118

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Boston, Massachusetts, United States

Local Institution - 113

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Detroit, Michigan, United States

Local Institution - 106

🇺🇸

Rochester, Minnesota, United States

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Local Institution - 119
🇺🇸Denver, Colorado, United States

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