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)

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Celgene

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Carfilzomib
Drug: CC-92480
Drug: Elotuzumab
Drug: Dexamethasone
Drug: Isatuximab
Drug: Daratumumab
Drug: Bortezomib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03989414
U1111-1233-5619 (Other Identifier)
2018-004767-31 (EudraCT Number)
CC-92480-MM-002

Details and patient eligibility

About

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

Enrollment

424 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

424 participants in 15 patient groups

Cohort A: CC-92480 with bortezomib and dexamethasone
Experimental group
Treatment:
Drug: Bortezomib
Drug: Dexamethasone
Drug: CC-92480
Cohort C: CC-92480 with carfilzomib and dexamethasone
Experimental group
Treatment:
Drug: Dexamethasone
Drug: CC-92480
Drug: Carfilzomib
Cohort H: CC-92480 with elotuzumab and dexamethasone
Experimental group
Treatment:
Drug: Dexamethasone
Drug: Elotuzumab
Drug: CC-92480
Cohort I: CC-92480 with isatuximab and dexamethasone
Experimental group
Treatment:
Drug: Isatuximab
Drug: Dexamethasone
Drug: CC-92480
Cohort D: CC-92480 with bortezomib and dexamethasone
Experimental group
Treatment:
Drug: Bortezomib
Drug: Dexamethasone
Drug: CC-92480
Cohort F: CC-92480 with carfilzomib and dexamethasone
Experimental group
Treatment:
Drug: Dexamethasone
Drug: CC-92480
Drug: Carfilzomib
Cohort J: CC-92480 with elotuzumab and dexamethasone
Experimental group
Treatment:
Drug: Dexamethasone
Drug: Elotuzumab
Drug: CC-92480
Cohort K: CC-92480 with isatuximab and dexamethasone
Experimental group
Treatment:
Drug: Isatuximab
Drug: Dexamethasone
Drug: CC-92480
Cohort G: CC-92480 with bortezomib and dexamethasone
Experimental group
Treatment:
Drug: Bortezomib
Drug: Dexamethasone
Drug: CC-92480
Subcohort B1: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480
Subcohort B2: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480
Subcohort B3: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480
Subcohort E1: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480
Subcohort E2: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480
Subcohort E3: CC-92480 with daratumumab and dexamethasone
Experimental group
Treatment:
Drug: Daratumumab
Drug: Dexamethasone
Drug: CC-92480

Trial contacts and locations

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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