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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)

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ClinicalTrials.gov Identifier: NCT03989414
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date January 17, 2023
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2022)
  • Recommended Dose [ Time Frame: Up to approximately 3 years ]
  • Recommended regimen as measured by dose-limiting toxicities [ Time Frame: 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 ]
  • Overall response rate (ORR) [ Time Frame: Up to approximately 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Dose-limiting Toxicities (DLT) [ Time Frame: UP to approximately 2 years from enrollment ]
    Number of participants with DLTs in the first cycle of the treatment
  • Adverse Events (AEs) [ Time Frame: From first subject first visit until 28 days after the last subject discontinues study treatment. ]
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment
  • Overall response rate (ORR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Defined as the proportion of subjects who achieve partial response (PR)or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria .
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2022)
  • Time-to-response (TTR) [ Time Frame: Up to approximately 5 years ]
  • Duration of response (DOR) [ Time Frame: Up to approximately 5 years ]
  • Complete Response (CR) rate [ Time Frame: Up to approximately 5 years ]
  • Very good partial response (VGPR) rate - Cohorts D and E [ Time Frame: Up to approximately 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Time-to-response (TTR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Time from first dose to the first documentation of response (PR or greater)
  • Duration of response (DOR) [ Time Frame: Up to approximately 3 years from enrollment ]
    Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death
  • Complete Response (CR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria
  • Very good partial response (VGPR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Carfilzomib
  • Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Elotuzumab
  • Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Isatuximab
  • Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Carfilzomib
  • Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Elotuzumab
  • Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Isatuximab
  • Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
  • Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
  • Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
  • Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
  • Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
  • Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
    • Drug: Daratumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2023)
424
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2019)
238
Estimated Study Completion Date  ICMJE July 31, 2026
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
Listed Location Countries  ICMJE Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989414
Other Study ID Numbers  ICMJE CC-92480-MM-002
U1111-1233-5619 ( Other Identifier: WHO )
2018-004767-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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/

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP