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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)

  • Clinicaltrials.gov identifier

    NCT03989414

  • Recruitment Status

    Recruiting

  • First Posted

    June 18, 2019

  • Last update posted

    September 8, 2022

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:Multiple Myeloma
  • Intervention/Treatment: Drug: Carfilzomib
    Drug: CC-92480
    Drug: Bortezomib
    Drug: Dexamethasone
    Drug: Daratumumab
    Drug: Carfilzomib
    Drug: Elotuzumab
    Drug: Isatuximab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 384 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official 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)
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: January 2025
  • Estimated Study Completion Date: July 2026

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 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 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: 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 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: 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 [ Time Frame: Up to approximately 3 years ]
  • 2. Recommended regimen as measured by dose-limiting toxicities [ Time Frame: Up to approximately 3 years ]
  • 3. 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 ]
  • 4. Overall response rate (ORR) [ Time Frame: Up to approximately 5 years ]
  • Secondary Outcome Measures: 1. Time-to-response (TTR) [ Time Frame: Up to approximately 5 years ]
  • 2. Duration of response (DOR) [ Time Frame: Up to approximately 5 years ]
  • 3. Complete Response (CR) rate [ Time Frame: Up to approximately 5 years ]
  • 4. Very good partial response (VGPR) rate - Cohorts D and E [ Time Frame: Up to approximately 5 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts

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 #.

Locations

United States, Massachusetts
Dana-Farber/Mass General Brigham Cancer Care, Inc
Boston

United States, Colorado
Colorado Blood Cancer Institute
Denver

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa

United States, Georgia
Winship Cancer Institute of Emory University
Atlanta

United States, Georgia
Winship Cancer Institute of Emory University
Atlanta

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago

United States, Illinois
University of Chicago Medicine
Chicago

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Michigan
Barbara Ann Karmanos Cancer Center
Detroit

United States, Minnesota
Mayo Clinic
Rochester

United States, New Jersey
Hackensack University Medical Center
Hackensack

United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem

United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus

United States, Tennessee
Sarah Cannon Cancer Center
Nashville

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Washington
Swedish Cancer Institute
Seattle

Canada, Alberta
Local Institution - 201
Calgary

Canada, Alberta
Tom Baker Cancer Center
Calgary

Canada, Alberta
University of Alberta - Faculty of Medicine and Dentistry
Edmonton

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax

Canada, Ontario
Princess Margaret Cancer Centre
Toronto

Canada, Quebec
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal

Czechia
Fakultni Nemocnice Brno
Brno

Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba

Czechia
Charles University General Hospital
Praha 2

Denmark
Odense University Hospital
Odense

Denmark
Vejle Hospital
Vejle

France
Hopital Claude Huriez CHRU Lille
Lille cedex

France
Local Institution - 703
Lille cedex

France
Institut Paoli Calmette Hematologie
Marseille cedex

France
Hotel Dieu CHU Nantes
Nantes Cedex 01

France
Local Institution - 704
Nantes Cedex 01

France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse Cedex 9

France
CHRU Hopital Bretonneau
Tours cedex

Germany
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin

Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
Freiburg

Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg

Germany
Local Institution - 601
Heidelberg

Germany
Universitaetsklinikum Heidelberg
Heidelberg

Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen

Germany
Universitaets-klinikum Wuerzburg
Wuerzburg

Greece
Alexandra General Hospital of Athens
Athens

Greece
Local Institution - 301
Athens

Italy
ASST Spedali Civili P.O. di Brescia
Brescia

Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan

Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia

Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino

Spain
Hopsital Germans Trias I Pujol
Badalona

Spain
Local Institution - 504
Badalona

Spain
Local Institution - 508
Madrid

Spain
Hospital Universitario 12 de Octubre
Madrid

Spain
Local Institution - 501
Madrid

Spain
Hospital Universitario Virgen de la Victoria
Malaga

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Local Institution - 505
Pamplona

Spain
Hospital Universitario de Salamanca
Salamanca

Spain
Hospital Universtario Marques de Valdecilla
Santander

Spain
Hospital Universitario y Politecnico La Fe
Valencia

Spain
Local Institution - 507
Valencia

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03989414 History of Changes
  • Other Study ID Numbers: CC-92480-MM-002, U1111-1233-5619, 2018-004767-31
  • First Posted: June 18, 2019 Key Record Dates
  • Last Update Posted: September 8, 2022
  • Last Verified: September 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • 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, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Relapsed or Refractory Multiple Myeloma
    Newly Diagnosed Multiple Myeloma
    Multiple Myeloma
    CC-92480
  • Additional relevant MeSH terms: Multiple Myeloma
    Neoplasms, Plasma Cell
    Neoplasms by Histologic Type
    Neoplasms
    Hemostatic Disorders
    Vascular Diseases
    Cardiovascular Diseases
    Paraproteinemias
    Blood Protein Disorders
    Hematologic Diseases
    Hemorrhagic Disorders
    Lymphoproliferative Disorders
    Immunoproliferative Disorders
    Immune System Diseases