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)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone
|
Drug: CC-92480
Specified dose on specified days
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
Drug: Dexamethasone
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
|
Experimental: Cohort H: CC-92480 with elotuzumab and dexamathasone
|
Drug: CC-92480
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Drug: Elotuzumab
Specified dose on specified days
|
Experimental: Cohort I: CC-92480 with isatuximab and dexamathasone
|
Drug: CC-92480
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Drug: Isatuximab
Specified dose on specified days
|
Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone
|
Drug: CC-92480
Specified dose on specified days
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
Drug: Dexamethasone
Specified dose on specified days
Drug: Carfilzomib
Specified dose on specified days
|
Experimental: Cohort J: CC-92480 with elotuzumab and dexamathasone
|
Drug: CC-92480
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Drug: Elotuzumab
Specified dose on specified days
|
Experimental: Cohort K: CC-92480 with isatuximab and dexamathasone
|
Drug: CC-92480
Specified dose on specified days
Drug: Dexamethasone
Specified dose on specified days
Drug: Isatuximab
Specified dose on specified days
|
Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone
|
Drug: CC-92480
Specified dose on specified days
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
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
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
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
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
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
Drug: Dexamethasone
Specified dose on specified days
Drug: Daratumumab
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Recommended Dose [Up to approximately 3 years]
- Recommended regimen as measured by dose-limiting toxicities [Up to approximately 3 years]
- Number of participants with Adverse Events (AEs) [From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years]
- Overall response rate (ORR) [Up to approximately 5 years]
Secondary Outcome Measures
- Time-to-response (TTR) [Up to approximately 5 years]
- Duration of response (DOR) [Up to approximately 5 years]
- Complete Response (CR) rate [Up to approximately 5 years]
- Very good partial response (VGPR) rate - Cohorts D and E [Up to approximately 5 years]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
2 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
3 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
4 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
5 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
6 | University of Chicago Medicine | Chicago | Illinois | United States | 60637 |
7 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
8 | Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts | United States | 02115 |
9 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
10 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
11 | Barbara Ann Karmanos Cancer Center | Detroit | Michigan | United States | 48201 |
12 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
13 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
14 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
15 | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
16 | Sarah Cannon Cancer Center | Nashville | Tennessee | United States | 37203 |
17 | The University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
18 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
19 | Tom Baker Cancer Center | Calgary | Alberta | Canada | T2N 4N2 |
20 | University of Alberta - Faculty of Medicine and Dentistry | Edmonton | Alberta | Canada | T6G 2G3 |
21 | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
22 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
23 | Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal | Montreal | Quebec | Canada | H1T 2M4 |
24 | Fakultni Nemocnice Brno | Brno | Czechia | 625 00 | |
25 | Fakultni Nemocnice Ostrava | Ostrava-Poruba | Czechia | 708 52 | |
26 | Charles University General Hospital | Praha 2 | Czechia | 128 08 | |
27 | Odense University Hospital | Odense | Denmark | 5000 | |
28 | Vejle Hospital | Vejle | Denmark | 7100 | |
29 | Hopital Claude Huriez CHRU Lille | Lille cedex | France | 59037 | |
30 | Local Institution - 703 | Lille cedex | France | 59037 | |
31 | Institut Paoli Calmette Hematologie | Marseille cedex | France | 13273 | |
32 | Hotel Dieu CHU Nantes | Nantes Cedex 01 | France | 44093 | |
33 | Local Institution - 704 | Nantes Cedex 01 | France | 44093 | |
34 | Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole | Toulouse Cedex 9 | France | 31059 | |
35 | CHRU Hopital Bretonneau | Tours cedex | France | 37044 | |
36 | Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin | Berlin | Germany | 12203 | |
37 | Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik | Freiburg | Germany | 79106 | |
38 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
39 | Universitaetsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
40 | Klinikum rechts der Isar der Technischen Universitaet Muenchen | Munchen | Germany | 81675 | |
41 | Universitaets-klinikum Wuerzburg | Wuerzburg | Germany | 97080 | |
42 | Alexandra General Hospital of Athens | Athens | Greece | 115 28 | |
43 | ASST Spedali Civili P.O. di Brescia | Brescia | Italy | 25123 | |
44 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy | 20133 | |
45 | Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova | Reggio Emilia | Italy | 42100 | |
46 | Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Torino | Italy | 10126 | |
47 | Hopsital Germans Trias I Pujol | Badalona | Spain | 08916 | |
48 | Local Institution - 504 | Badalona | Spain | 08916 | |
49 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
50 | Hospital Universitario Virgen de la Victoria | Malaga | Spain | 29010 | |
51 | Clinica Universidad de Navarra | Pamplona | Spain | 31008 | |
52 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 | |
53 | Hospital Universtario Marques de Valdecilla | Santander | Spain | 39008 | |
54 | Hospital Universitario y Politecnico La Fe | Valencia | Spain | 46026 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- FDA Safety Alerts and Recalls
- Investigator Inquiry Form
Publications
None provided.- CC-92480-MM-002
- U1111-1233-5619
- 2018-004767-31