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)

November 26, 2024 updated by: Celgene

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

424

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 201
      • Edmonton, Alberta, Canada, T6G 2G3
        • Local Institution - 205
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Local Institution - 204
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 203
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 202
  • Czechia
      • Brno, Czechia, 625 00
        • Local Institution - 802
      • Ostrava-Poruba, Czechia, 708 52
        • Local Institution - 801
      • Praha 2, Czechia, 128 08
        • Local Institution - 803
  • Denmark
      • Odense, Denmark, 5000
        • Local Institution - 902
      • Vejle, Denmark, 7100
        • Local Institution - 903
  • France
      • Lille cedex, France, 59037
        • Local Institution - 703
      • Marseille cedex, France, 13273
        • Local Institution - 705
      • Nantes Cedex 01, France, 44093
        • Local Institution - 704
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 701
      • Tours cedex, France, 37044
        • Local Institution - 702
  • Germany
      • Freiburg, Germany, 79106
        • Local Institution - 604
      • Hamburg, Germany, 20246
        • Local Institution - 605
      • Heidelberg, Germany, 69120
        • Local Institution - 601
      • Munchen, Germany, 81675
        • Local Institution - 602
      • Wuerzburg, Germany, 97080
        • Local Institution - 603
  • Greece
      • Athens, Greece, 115 28
        • Local Institution - 301
  • Italy
      • Brescia, Italy, 25123
        • Local Institution - 404
      • Milan, Italy, 20133
        • Local Institution - 401
      • Reggio Emilia, Italy, 42100
        • Local Institution - 403
      • Torino, Italy, 10126
        • Local Institution - 402
  • Spain
      • Badalona, Spain, 08916
        • Local Institution - 504
      • Madrid, Spain, 28022
        • Local Institution - 508
      • Madrid, Spain, 28041
        • Local Institution - 501
      • Malaga, Spain, 29010
        • Local Institution - 506
      • Pamplona, Spain, 31008
        • Local Institution - 505
      • Salamanca, Spain, 37007
        • Local Institution - 502
      • Santander, Spain, 39008
        • Local Institution - 503
      • Valencia, Spain, 46026
        • Local Institution - 507
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Local Institution - 119
    • Florida
      • Tampa, Florida, United States, 33612
        • Local Institution - 104
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 108
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 107
      • Chicago, Illinois, United States, 60611
        • Local Institution - 112
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 117
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 101
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 118
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Local Institution - 113
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 106
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution - 110
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution - 115
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 114
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 116
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Bortezomib
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Bortezomib
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Bortezomib
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Elotuzumab
Specified dose on specified days
Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Isatuximab
Specified dose on specified days
Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Elotuzumab
Specified dose on specified days
Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
Drug: CC-92480
Specified dose on specified days
Other Names:
  • BMS-986348
  • mezigdomide
Drug: Dexamethasone
Specified dose on specified days
Drug: Isatuximab
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
Duration of response (DOR)
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Complete Response (CR) rate
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Very good partial response (VGPR) rate - Cohorts D and E
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-92480-MM-002
  • U1111-1233-5619 (Other Identifier: WHO)
  • 2023-505219-19 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

See Plan Description

IPD Sharing Access Criteria

See Plan Description

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

Yes

Studies a U.S. FDA-regulated device product

No

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.

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