Back to resultsA 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)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-92480
Bortezomib
Dexamethasone
Daratumumab
Carfilzomib
Elotuzumab
Isatuximab
Carfilzomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed or Refractory Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480
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
Sites / Locations
- Local Institution - 119
- Local Institution - 104
- Winship Cancer Institute of Emory UniversityRecruiting
- Local Institution - 112
- Local Institution - 107
- Massachusetts General HospitalRecruiting
- Dana-Farber/Mass General Brigham Cancer Care, IncRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- Barbara Ann Karmanos Cancer CenterRecruiting
- Local Institution - 106
- Hackensack University Medical Center
- Local Institution - 110
- The Ohio State University Comprehensive Cancer CenterRecruiting
- Local Institution - 114
- The University of Texas - MD Anderson Cancer CenterRecruiting
- Swedish Cancer Institute
- Local Institution - 201Recruiting
- Local Institution - 205Recruiting
- Local Institution - 204Recruiting
- Local Institution - 203Recruiting
- Local Institution - 202Recruiting
- Local Institution - 802Recruiting
- Local Institution - 801
- Local Institution - 803
- Local Institution - 902Recruiting
- Local Institution - 903
- Local Institution - 703Recruiting
- Local Institution - 705Recruiting
- Local Institution - 704Recruiting
- Local Institution - 701Recruiting
- Local Institution - 702Recruiting
- Local Institution - 606
- Local Institution - 604Recruiting
- Local Institution - 605
- Local Institution - 601Recruiting
- Local Institution - 602
- Local Institution - 603Recruiting
- Local Institution - 301Recruiting
- Local Institution - 404Recruiting
- Local Institution - 401Recruiting
- Local Institution - 403
- Local Institution - 402
- Local Institution - 504Recruiting
- Local Institution - 508Recruiting
- Local Institution - 501Recruiting
- Local Institution - 506Recruiting
- Local Institution - 505Recruiting
- Local Institution - 502Recruiting
- Local Institution - 503Recruiting
- Local Institution - 507Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A: CC-92480 with bortezomib and dexamethasone
Cohort C: CC-92480 with carfilzomib and dexamethasone
Cohort H: CC-92480 with elotuzumab and dexamethasone
Cohort I: CC-92480 with isatuximab and dexamethasone
Cohort D: CC-92480 with bortezomib and dexamethasone
Cohort F: CC-92480 with carfilzomib and dexamethasone
Cohort J: CC-92480 with elotuzumab and dexamethasone
Cohort K: CC-92480 with isatuximab and dexamethasone
Cohort G: CC-92480 with bortezomib and dexamethasone
Subcohort B1: CC-92480 with daratumumab and dexamethasone
Subcohort B2: CC-92480 with daratumumab and dexamethasone
Subcohort B3: CC-92480 with daratumumab and dexamethasone
Subcohort E1: CC-92480 with daratumumab and dexamethasone
Subcohort E2: CC-92480 with daratumumab and dexamethasone
Subcohort E3: CC-92480 with daratumumab and dexamethasone
Arm Description
Outcomes
Primary Outcome Measures
Recommended Dose
Recommended regimen as measured by dose-limiting toxicities
Number of participants with Adverse Events (AEs)
Overall response rate (ORR)
Secondary Outcome Measures
Time-to-response (TTR)
Duration of response (DOR)
Complete Response (CR) rate
Very good partial response (VGPR) rate - Cohorts D and E
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03989414
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed or Refractory Multiple Myeloma, Newly Diagnosed Multiple Myeloma, Multiple Myeloma, CC-92480
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
424 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: CC-92480 with bortezomib and dexamethasone
Arm Type
Experimental
Arm Title
Cohort C: CC-92480 with carfilzomib and dexamethasone
Arm Type
Experimental
Arm Title
Cohort H: CC-92480 with elotuzumab and dexamethasone
Arm Type
Experimental
Arm Title
Cohort I: CC-92480 with isatuximab and dexamethasone
Arm Type
Experimental
Arm Title
Cohort D: CC-92480 with bortezomib and dexamethasone
Arm Type
Experimental
Arm Title
Cohort F: CC-92480 with carfilzomib and dexamethasone
Arm Type
Experimental
Arm Title
Cohort J: CC-92480 with elotuzumab and dexamethasone
Arm Type
Experimental
Arm Title
Cohort K: CC-92480 with isatuximab and dexamethasone
Arm Type
Experimental
Arm Title
Cohort G: CC-92480 with bortezomib and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort B1: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort B2: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort B3: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort E1: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort E2: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Arm Title
Subcohort E3: CC-92480 with daratumumab and dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-92480
Other Intervention Name(s)
BMS-986348, mezigdomide
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Elotuzumab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Isatuximab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Recommended Dose
Time Frame
Up to approximately 3 years
Title
Recommended regimen as measured by dose-limiting toxicities
Time Frame
Up to approximately 3 years
Title
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
Title
Overall response rate (ORR)
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Time-to-response (TTR)
Time Frame
Up to approximately 5 years
Title
Duration of response (DOR)
Time Frame
Up to approximately 5 years
Title
Complete Response (CR) rate
Time Frame
Up to approximately 5 years
Title
Very good partial response (VGPR) rate - Cohorts D and E
Time Frame
Up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 119
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 104
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Completed
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Hofmeister, Site 108
Phone
404-778-8580
Facility Name
Local Institution - 112
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 107
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noopur Raje, Site 117
Phone
617-726-0711
Facility Name
Dana-Farber/Mass General Brigham Cancer Care, Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Richardson, Site 101
Phone
617-632-6624
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacalyn Rosenblatt, Site 118
Phone
617-667-9920
Facility Name
Barbara Ann Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Zonder, Site 113
Phone
313-576-8730
Facility Name
Local Institution - 106
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 110
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naresh Bumma, Site 115
Phone
614-292-6307
Facility Name
Local Institution - 114
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Completed
Facility Name
The University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Orlowski, Site 116
Phone
713-792-2860
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 201
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
Facility Name
Local Institution - 205
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 205
Facility Name
Local Institution - 204
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 204
Facility Name
Local Institution - 203
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 203
Facility Name
Local Institution - 202
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 202
Facility Name
Local Institution - 802
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 802
Facility Name
Local Institution - 801
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Completed
Facility Name
Local Institution - 803
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Completed
Facility Name
Local Institution - 902
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 902
Facility Name
Local Institution - 903
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Completed
Facility Name
Local Institution - 703
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 703
Facility Name
Local Institution - 705
City
Marseille cedex
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 705
Facility Name
Local Institution - 704
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 704
Facility Name
Local Institution - 701
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 701
Facility Name
Local Institution - 702
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 702
Facility Name
Local Institution - 606
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 604
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 604
Facility Name
Local Institution - 605
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Completed
Facility Name
Local Institution - 601
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 601
Facility Name
Local Institution - 602
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Completed
Facility Name
Local Institution - 603
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 603
Facility Name
Local Institution - 301
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 301
Facility Name
Local Institution - 404
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 404
Facility Name
Local Institution - 401
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 401
Facility Name
Local Institution - 403
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Completed
Facility Name
Local Institution - 402
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Completed
Facility Name
Local Institution - 504
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 504
Facility Name
Local Institution - 508
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 508
Facility Name
Local Institution - 501
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 501
Facility Name
Local Institution - 506
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 506
Facility Name
Local Institution - 505
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 505
Facility Name
Local Institution - 502
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 502
Facility Name
Local Institution - 503
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 503
Facility Name
Local Institution - 507
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 507
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
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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