- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989414
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)
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Contact Backup
- Name: First line of the email MUST contain the NCT# and Site #.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Recruiting
- Local Institution - 201
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Contact:
- Site 201
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Edmonton, Alberta, Canada, T6G 2G3
- Recruiting
- Local Institution - 205
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Contact:
- Site 205
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Recruiting
- Local Institution - 204
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Contact:
- Site 204
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Local Institution - 203
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Contact:
- Site 203
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- Local Institution - 202
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Contact:
- Site 202
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Brno, Czechia, 625 00
- Recruiting
- Local Institution - 802
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Contact:
- Site 802
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Ostrava-Poruba, Czechia, 708 52
- Completed
- Local Institution - 801
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Praha 2, Czechia, 128 08
- Completed
- Local Institution - 803
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Odense, Denmark, 5000
- Recruiting
- Local Institution - 902
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Contact:
- Site 902
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Vejle, Denmark, 7100
- Completed
- Local Institution - 903
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Lille cedex, France, 59037
- Recruiting
- Local Institution - 703
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Contact:
- Site 703
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Marseille cedex, France, 13273
- Recruiting
- Local Institution - 705
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Contact:
- Site 705
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Nantes Cedex 01, France, 44093
- Recruiting
- Local Institution - 704
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Contact:
- Site 704
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Toulouse Cedex 9, France, 31059
- Recruiting
- Local Institution - 701
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Contact:
- Site 701
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Tours cedex, France, 37044
- Recruiting
- Local Institution - 702
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Contact:
- Site 702
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Berlin, Germany, 12203
- Withdrawn
- Local Institution - 606
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Freiburg, Germany, 79106
- Recruiting
- Local Institution - 604
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Contact:
- Site 604
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Hamburg, Germany, 20246
- Completed
- Local Institution - 605
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Heidelberg, Germany, 69120
- Recruiting
- Universitaetsklinikum Heidelberg
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Contact:
- Marc Raab, Site 601
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Munchen, Germany, 81675
- Completed
- Local Institution - 602
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Wuerzburg, Germany, 97080
- Recruiting
- Local Institution - 603
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Contact:
- Site 603
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Athens, Greece, 115 28
- Recruiting
- Local Institution - 301
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Contact:
- Site 301
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Brescia, Italy, 25123
- Recruiting
- Local Institution - 404
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Contact:
- Site 404
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Milan, Italy, 20133
- Recruiting
- Local Institution - 401
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Contact:
- Site 401
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Reggio Emilia, Italy, 42100
- Completed
- Local Institution - 403
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Torino, Italy, 10126
- Completed
- Local Institution - 402
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Badalona, Spain, 08916
- Recruiting
- Local Institution - 504
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Contact:
- Site 504
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Madrid, Spain, 28041
- Recruiting
- Local Institution - 501
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Contact:
- Site 501
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Madrid, Spain, 28022
- Completed
- Local Institution - 508
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Malaga, Spain, 29010
- Recruiting
- Local Institution - 506
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Contact:
- Site 506
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Pamplona, Spain, 31008
- Recruiting
- Local Institution - 505
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Contact:
- Site 505
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Salamanca, Spain, 37007
- Recruiting
- Local Institution - 502
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Contact:
- Site 502
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Santander, Spain, 39008
- Recruiting
- Local Institution - 503
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Contact:
- Site 503
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Valencia, Spain, 46026
- Recruiting
- Local Institution - 507
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Contact:
- Site 507
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Colorado
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Denver, Colorado, United States, 80218
- Completed
- Local Institution - 119
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Florida
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Tampa, Florida, United States, 33612
- Completed
- Local Institution - 104
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Winship Cancer Institute of Emory University
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Contact:
- Craig Hofmeister, Site 108
- Phone Number: 404-778-8580
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Illinois
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Chicago, Illinois, United States, 60611
- Completed
- Local Institution - 112
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Chicago, Illinois, United States, 60637
- Completed
- Local Institution - 107
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
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Contact:
- Noopur Raje, Site 117
- Phone Number: 617-726-0711
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Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
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Contact:
- Jacalyn Rosenblatt, Site 118
- Phone Number: 617-667-9920
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Boston, Massachusetts, United States, 02115
- Recruiting
- Dana-Farber/Mass General Brigham Cancer Care, Inc
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Contact:
- Paul Richardson, Site 101
- Phone Number: 617-632-6624
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Michigan
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Detroit, Michigan, United States, 48201
- Recruiting
- Barbara Ann Karmanos Cancer Center
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Contact:
- Jeffrey Zonder, Site 113
- Phone Number: 313-576-8730
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Minnesota
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Rochester, Minnesota, United States, 55905
- Completed
- Local Institution - 106
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Completed
- Hackensack University Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Completed
- Local Institution - 110
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Comprehensive Cancer Center
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Contact:
- Naresh Bumma, Site 115
- Phone Number: 614-292-6307
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Tennessee
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Nashville, Tennessee, United States, 37203
- Completed
- Local Institution - 114
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas - MD Anderson Cancer Center
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Contact:
- Robert Orlowski, Site 116
- Phone Number: 713-792-2860
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Washington
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Seattle, Washington, United States, 98104
- Completed
- Swedish Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
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Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
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Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
|
Specified dose on specified days
Other Names:
Specified dose on specified days
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recommended Dose
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Recommended regimen as measured by dose-limiting toxicities
Time Frame: Up to approximately 3 years
|
Up to approximately 3 years
|
Number of participants with Adverse Events (AEs)
Time Frame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
|
From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
|
Overall response rate (ORR)
Time Frame: Up to approximately 5 years
|
Up to approximately 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-to-response (TTR)
Time Frame: Up to approximately 5 years
|
Up to approximately 5 years
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Duration of response (DOR)
Time Frame: Up to approximately 5 years
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Up to approximately 5 years
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Complete Response (CR) rate
Time Frame: Up to approximately 5 years
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Up to approximately 5 years
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Very good partial response (VGPR) rate - Cohorts D and E
Time Frame: Up to approximately 5 years
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Up to approximately 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Daratumumab
- Bortezomib
- Elotuzumab
Other Study ID Numbers
- CC-92480-MM-002
- U1111-1233-5619 (Other Identifier: WHO)
- 2018-004767-31 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
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-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on CC-92480
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CelgeneCompleted
-
CelgeneCompletedHealthy VolunteersUnited States
-
Bristol-Myers SquibbCompletedHepatic ImpairmentUnited States
-
CelgeneNot yet recruitingRenal ImpairmentUnited States
-
Juno Therapeutics, Inc., a Bristol-Myers Squibb...Recruiting
-
CelgeneCompletedHealthy VolunteersUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMultiple MyelomaUnited States
-
CelgeneCompletedHealthy VolunteerUnited States
-
CelgeneRecruitingMultiple MyelomaUnited States, Israel, Spain, Denmark, France, Germany, Netherlands
-
CelgeneActive, not recruitingMultiple MyelomaUnited States, Canada, Denmark, Australia, Belgium, Finland, Greece, Japan, Korea, Republic of, Spain, United Kingdom