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)

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03989414
Collaborator
(none)
384
54
15
65.5
7.1
0.1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Sep 30, 2019
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Mar 16, 2025

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

  1. Recommended Dose [Up to approximately 3 years]

  2. Recommended regimen as measured by dose-limiting toxicities [Up to approximately 3 years]

  3. 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]

  4. Overall response rate (ORR) [Up to approximately 5 years]

Secondary Outcome Measures

  1. Time-to-response (TTR) [Up to approximately 5 years]

  2. Duration of response (DOR) [Up to approximately 5 years]

  3. Complete Response (CR) rate [Up to approximately 5 years]

  4. Very good partial response (VGPR) rate - Cohorts D and E [Up to approximately 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Publications

None provided.
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT03989414
Other Study ID Numbers:
  • CC-92480-MM-002
  • U1111-1233-5619
  • 2018-004767-31
First Posted:
Jun 18, 2019
Last Update Posted:
Aug 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celgene
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022