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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Full Title:
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)
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 1/Phase 2
Summary/Purpose:
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
Detailed Description:
Not available
Treatments:
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

Study 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
Study Type:
Interventional
Study Design:
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Recruitment status:
Recruiting
Eligibility 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
Locations / Centres:

Local Institution - 201, Calgary, Alberta – Recruiting

Local Institution - 205, Edmonton, Alberta – Recruiting

Local Institution - 204, Halifax, Nova Scotia – Recruiting

Local Institution - 203, Toronto, Ontario – Recruiting

Local Institution - 202, Montreal, Quebec – Recruiting

Contacts:
Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
Publications:
???
First posted:
2019-06-18
Actual start date:
September 30, 2019
Last updated:
2024-01-08
Estimated enrollment:
424
Estimated completion date:
2026-11-30
Estimated primary completion date:
2026-11-30
Condition:
Multiple Myeloma
Gender:
All
Ages:
18 Years-N/A
Accepts healthy volunteers:
No
Listed location countries:
Canada
Czechia
Denmark
France
Germany
Greece
Italy
Spain
United States
NCT number:
NCT03989414
Other study ID numbers:
CC-92480-MM-002
Has Data monitoring committee:
Yes
U.S. FDA-regulated product:
Yes
IPD Sharing Statement :
???
Responsible party:
Sponsor
Study sponsor:
lead_sponsor
Celgene
Industry
Collaborators:
???
Investigators:
Bristol-Myers Squibb Bristol-Myers Squibb
Protocol Registration and Results System:
???
Verification date:
2024-01-01