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)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03989414
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Czechia, Denmark, France, Germany, Greece, Italy, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

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

Interventions

Drug: - CC-92480

Specified dose on specified days

Drug: - Bortezomib

Specified dose on specified days

Drug: - Dexamethasone

Specified dose on specified days

Drug: - Daratumumab

Specified dose on specified days

Drug: - Carfilzomib

Specified dose on specified days

Drug: - Elotuzumab

Specified dose on specified days

Drug: - Isatuximab

Specified dose on specified days

Drug: - Carfilzomib

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Local Institution - 119, Denver, Colorado

Status

Completed

Address

Local Institution - 119

Denver, Colorado, 80218

Local Institution - 104, Tampa, Florida

Status

Completed

Address

Local Institution - 104

Tampa, Florida, 33612

Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Site Contact

Craig Hofmeister, Site 108

Clinical.Trials@bms.com

404-778-8580

Local Institution - 112, Chicago, Illinois

Status

Completed

Address

Local Institution - 112

Chicago, Illinois, 60611

Local Institution - 107, Chicago, Illinois

Status

Completed

Address

Local Institution - 107

Chicago, Illinois, 60637

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Noopur Raje, Site 117

Clinical.Trials@bms.com

617-726-0711

Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber/Mass General Brigham Cancer Care, Inc

Boston, Massachusetts, 02115

Site Contact

Paul Richardson, Site 101

Clinical.Trials@bms.com

617-632-6624

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Jacalyn Rosenblatt, Site 118

Clinical.Trials@bms.com

617-667-9920

Barbara Ann Karmanos Cancer Center, Detroit, Michigan

Status

Recruiting

Address

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201

Site Contact

Jeffrey Zonder, Site 113

Clinical.Trials@bms.com

313-576-8730

Local Institution - 106, Rochester, Minnesota

Status

Completed

Address

Local Institution - 106

Rochester, Minnesota, 55905

Hackensack University Medical Center, Hackensack, New Jersey

Status

Completed

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Local Institution - 110, Winston-Salem, North Carolina

Status

Completed

Address

Local Institution - 110

Winston-Salem, North Carolina, 27157

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Site Contact

Naresh Bumma, Site 115

Clinical.Trials@bms.com

614-292-6307

Local Institution - 114, Nashville, Tennessee

Status

Completed

Address

Local Institution - 114

Nashville, Tennessee, 37203

Houston, Texas

Status

Recruiting

Address

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Robert Orlowski, Site 116

Clinical.Trials@bms.com

713-792-2860

Swedish Cancer Institute, Seattle, Washington

Status

Completed

Address

Swedish Cancer Institute

Seattle, Washington, 98104

International Sites

Local Institution - 201, Calgary, Alberta, Canada

Status

Recruiting

Address

Local Institution - 201

Calgary, Alberta, T2N 4N2

Site Contact

Site 201

Clinical.Trials@bms.com

855-907-3286

Local Institution - 205, Edmonton, Alberta, Canada

Status

Recruiting

Address

Local Institution - 205

Edmonton, Alberta, T6G 2G3

Site Contact

Site 205

Clinical.Trials@bms.com

855-907-3286

Local Institution - 204, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

Local Institution - 204

Halifax, Nova Scotia, B3H 1V7

Site Contact

Site 204

Clinical.Trials@bms.com

855-907-3286

Local Institution - 203, Toronto, Ontario, Canada

Status

Recruiting

Address

Local Institution - 203

Toronto, Ontario, M5G 2M9

Site Contact

Site 203

Clinical.Trials@bms.com

855-907-3286

Local Institution - 202, Montreal, Quebec, Canada

Status

Recruiting

Address

Local Institution - 202

Montreal, Quebec, H1T 2M4

Site Contact

Site 202

Clinical.Trials@bms.com

855-907-3286

Local Institution - 802, Brno, Czechia

Status

Recruiting

Address

Local Institution - 802

Brno, , 625 00

Site Contact

Site 802

Clinical.Trials@bms.com

855-907-3286

Local Institution - 801, Ostrava-Poruba, Czechia

Status

Completed

Address

Local Institution - 801

Ostrava-Poruba, , 708 52

Local Institution - 803, Praha 2, Czechia

Status

Completed

Address

Local Institution - 803

Praha 2, , 128 08

Local Institution - 902, Odense, Denmark

Status

Recruiting

Address

Local Institution - 902

Odense, , 5000

Site Contact

Site 902

Clinical.Trials@bms.com

855-907-3286

Local Institution - 903, Vejle, Denmark

Status

Completed

Address

Local Institution - 903

Vejle, , 7100

Local Institution - 703, Lille cedex, France

Status

Recruiting

Address

Local Institution - 703

Lille cedex, , 59037

Site Contact

Site 703

Clinical.Trials@bms.com

855-907-3286

Local Institution - 705, Marseille cedex, France

Status

Recruiting

Address

Local Institution - 705

Marseille cedex, , 13273

Site Contact

Site 705

Clinical.Trials@bms.com

855-907-3286

Local Institution - 704, Nantes Cedex 01, France

Status

Recruiting

Address

Local Institution - 704

Nantes Cedex 01, , 44093

Site Contact

Site 704

Clinical.Trials@bms.com

855-907-3286

Local Institution - 701, Toulouse Cedex 9, France

Status

Recruiting

Address

Local Institution - 701

Toulouse Cedex 9, , 31059

Site Contact

Site 701

Clinical.Trials@bms.com

855-907-3286

Local Institution - 702, Tours cedex, France

Status

Recruiting

Address

Local Institution - 702

Tours cedex, , 37044

Site Contact

Site 702

Clinical.Trials@bms.com

855-907-3286

Local Institution - 606, Berlin, Germany

Status

Withdrawn

Address

Local Institution - 606

Berlin, , 12203

Local Institution - 604, Freiburg, Germany

Status

Recruiting

Address

Local Institution - 604

Freiburg, , 79106

Site Contact

Site 604

Clinical.Trials@bms.com

855-907-3286

Local Institution - 605, Hamburg, Germany

Status

Completed

Address

Local Institution - 605

Hamburg, , 20246

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69120

Site Contact

Marc Raab, Site 601

Clinical.Trials@bms.com

855-907-3286

Local Institution - 602, Munchen, Germany

Status

Completed

Address

Local Institution - 602

Munchen, , 81675

Local Institution - 603, Wuerzburg, Germany

Status

Recruiting

Address

Local Institution - 603

Wuerzburg, , 97080

Site Contact

Site 603

Clinical.Trials@bms.com

855-907-3286

Local Institution - 301, Athens, Greece

Status

Recruiting

Address

Local Institution - 301

Athens, , 115 28

Site Contact

Site 301

Clinical.Trials@bms.com

855-907-3286

Local Institution - 404, Brescia, Italy

Status

Recruiting

Address

Local Institution - 404

Brescia, , 25123

Site Contact

Site 404

Clinical.Trials@bms.com

855-907-3286

Local Institution - 401, Milan, Italy

Status

Recruiting

Address

Local Institution - 401

Milan, , 20133

Site Contact

Site 401

Clinical.Trials@bms.com

855-907-3286

Local Institution - 403, Reggio Emilia, Italy

Status

Completed

Address

Local Institution - 403

Reggio Emilia, , 42100

Local Institution - 402, Torino, Italy

Status

Completed

Address

Local Institution - 402

Torino, , 10126

Local Institution - 504, Badalona, Spain

Status

Recruiting

Address

Local Institution - 504

Badalona, , 08916

Site Contact

Site 504

Clinical.Trials@bms.com

855-907-3286

Local Institution - 508, Madrid, Spain

Status

Completed

Address

Local Institution - 508

Madrid, , 28022

Local Institution - 501, Madrid, Spain

Status

Recruiting

Address

Local Institution - 501

Madrid, , 28041

Site Contact

Site 501

Clinical.Trials@bms.com

855-907-3286

Local Institution - 506, Malaga, Spain

Status

Recruiting

Address

Local Institution - 506

Malaga, , 29010

Site Contact

Site 506

Clinical.Trials@bms.com

855-907-3286

Local Institution - 505, Pamplona, Spain

Status

Recruiting

Address

Local Institution - 505

Pamplona, , 31008

Site Contact

Site 505

Clinical.Trials@bms.com

855-907-3286

Local Institution - 502, Salamanca, Spain

Status

Recruiting

Address

Local Institution - 502

Salamanca, , 37007

Site Contact

Site 502

Clinical.Trials@bms.com

855-907-3286

Local Institution - 503, Santander, Spain

Status

Recruiting

Address

Local Institution - 503

Santander, , 39008

Site Contact

Site 503

Clinical.Trials@bms.com

855-907-3286

Local Institution - 507, Valencia, Spain

Status

Recruiting

Address

Local Institution - 507

Valencia, , 46026

Site Contact

Site 507

Clinical.Trials@bms.com

855-907-3286