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)

NCT ID: NCT03989414

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

424 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: CC-92480 with bortezomib and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Bortezomib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Cohort C: CC-92480 with carfilzomib and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Carfilzomib

Intervention Type DRUG

Specified dose on specified days

Cohort H: CC-92480 with elotuzumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Elotuzumab

Intervention Type DRUG

Specified dose on specified days

Cohort I: CC-92480 with isatuximab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Isatuximab

Intervention Type DRUG

Specified dose on specified days

Cohort D: CC-92480 with bortezomib and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Bortezomib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Cohort F: CC-92480 with carfilzomib and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Carfilzomib

Intervention Type DRUG

Specified dose on specified days

Cohort J: CC-92480 with elotuzumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Elotuzumab

Intervention Type DRUG

Specified dose on specified days

Cohort K: CC-92480 with isatuximab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Isatuximab

Intervention Type DRUG

Specified dose on specified days

Cohort G: CC-92480 with bortezomib and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Bortezomib

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Subcohort B1: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Subcohort B2: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Subcohort B3: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Subcohort E1: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Subcohort E2: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Subcohort E3: CC-92480 with daratumumab and dexamethasone

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Dexamethasone

Intervention Type DRUG

Specified dose on specified days

Daratumumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-92480

Specified dose on specified days

Intervention Type DRUG

Bortezomib

Specified dose on specified days

Intervention Type DRUG

Dexamethasone

Specified dose on specified days

Intervention Type DRUG

Daratumumab

Specified dose on specified days

Intervention Type DRUG

Carfilzomib

Specified dose on specified days

Intervention Type DRUG

Elotuzumab

Specified dose on specified days

Intervention Type DRUG

Isatuximab

Specified dose on specified days

Intervention Type DRUG

Carfilzomib

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986348 mezigdomide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 119

Denver, Colorado, United States

Site Status

Local Institution - 104

Tampa, Florida, United States

Site Status

Local Institution - 108

Atlanta, Georgia, United States

Site Status

Local Institution - 112

Chicago, Illinois, United States

Site Status

Local Institution - 107

Chicago, Illinois, United States

Site Status

Local Institution - 117

Boston, Massachusetts, United States

Site Status

Local Institution - 101

Boston, Massachusetts, United States

Site Status

Local Institution - 118

Boston, Massachusetts, United States

Site Status

Local Institution - 113

Detroit, Michigan, United States

Site Status

Local Institution - 106

Rochester, Minnesota, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Local Institution - 110

Winston-Salem, North Carolina, United States

Site Status

Local Institution - 115

Columbus, Ohio, United States

Site Status

Local Institution - 114

Nashville, Tennessee, United States

Site Status

Local Institution - 116

Houston, Texas, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Local Institution - 201

Calgary, Alberta, Canada

Site Status

Local Institution - 205

Edmonton, Alberta, Canada

Site Status

Local Institution - 204

Halifax, Nova Scotia, Canada

Site Status

Local Institution - 203

Toronto, Ontario, Canada

Site Status

Local Institution - 202

Montreal, Quebec, Canada

Site Status

Local Institution - 802

Brno, , Czechia

Site Status

Local Institution - 801

Ostrava-Poruba, , Czechia

Site Status

Local Institution - 803

Prague, , Czechia

Site Status

Local Institution - 902

Odense, , Denmark

Site Status

Local Institution - 903

Vejle, , Denmark

Site Status

Local Institution - 703

Lille, , France

Site Status

Local Institution - 705

Marseille, , France

Site Status

Local Institution - 704

Nantes, , France

Site Status

Local Institution - 701

Toulouse, , France

Site Status

Local Institution - 702

Tours, , France

Site Status

Local Institution - 604

Freiburg im Breisgau, , Germany

Site Status

Local Institution - 605

Hamburg, , Germany

Site Status

Local Institution - 601

Heidelberg, , Germany

Site Status

Local Institution - 602

München, , Germany

Site Status

Local Institution - 603

Würzburg, , Germany

Site Status

Local Institution - 301

Athens, , Greece

Site Status

Local Institution - 404

Brescia, , Italy

Site Status

Local Institution - 401

Milan, , Italy

Site Status

Local Institution - 403

Reggio Emilia, , Italy

Site Status

Local Institution - 402

Torino, , Italy

Site Status

Local Institution - 504

Badalona, , Spain

Site Status

Local Institution - 508

Madrid, , Spain

Site Status

Local Institution - 501

Madrid, , Spain

Site Status

Local Institution - 506

Málaga, , Spain

Site Status

Local Institution - 505

Pamplona, , Spain

Site Status

Local Institution - 502

Salamanca, , Spain

Site Status

Local Institution - 503

Santander, , Spain

Site Status

Local Institution - 507

Valencia, , Spain

Site Status

Countries

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United States Canada Czechia Denmark France Germany Greece Italy Spain

Related Links

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Other Identifiers

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U1111-1233-5619

Identifier Type: OTHER

Identifier Source: secondary_id

2023-505219-19

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC-92480-MM-002

Identifier Type: -

Identifier Source: org_study_id