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)

Celgene

Status and phase: Active, not recruiting; 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

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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