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A 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)

  • Clinicaltrials.gov identifier

    NCT03989414

  • Recruitment Status

    Recruiting

  • First Posted

    June 18, 2019

  • Last update posted

    March 2, 2021

Study Description

Brief summary:

This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: CC-92480
    Drug: Bortezomib
    Drug: Dexamethasone
    Drug: Daratumumab
    Drug: Carfilzomib
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 384 participants
  • Allocation: 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: September 2019
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: January 2025

Arms and interventions

Arm Intervention/treatment
Experimental: CC-92480 in combination with bortezomib and dexamethasone
Subjects in cohorts A, D and G will receive following: Oral CC-92480 at specified cohort dose administered over a 21-day cycle Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (>75 years old) administered over a 21-day cycle
Drug: CC-92480
CC-92480

Drug: Bortezomib
Bortezomib

Drug: Dexamethasone
Dexamethasone
Experimental: CC-92480 in combination with carfilzomib and dexamethasone
Subjects in cohort C and F will receive following: Oral CC-92480 at specified cohort dose administered over a 28-day cycle Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects >75 years old) administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Carfilzomib
Carfilzomib
Experimental: CC-92480 in combination with daratumumab and dexamethasone
Subjects in cohorts B and E will receive following: Oral CC-92480 at specified cohort dose administered over a 28-day cycle Intravenous (IV) daratumumab 16 mg/kg administered over a 28-day cycle Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle
Drug: CC-92480
CC-92480

Drug: Dexamethasone
Dexamethasone

Drug: Daratumumab
Daratumumab

Outcome Measures

  • Primary Outcome Measures: 1. Dose-limiting Toxicities (DLT) [ Time Frame: UP to approximately 2 years from enrollment ]
    Number of participants with DLTs in the first cycle of the treatment
  • 2. Adverse Events (AEs) [ Time Frame: From first subject first visit until 28 days after the last subject discontinues study treatment. ]
    Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment
  • 3. Overall response rate (ORR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Defined as the proportion of subjects who achieve partial response (PR)or better according to the International Myeloma Working Group (IMWG) Uniform Response Criteria .
  • Secondary Outcome Measures: 1. Time-to-response (TTR) [ Time Frame: UP to approximately 3 years from enrollment ]
    Time from first dose to the first documentation of response (PR or greater)
  • 2. Duration of response (DOR) [ Time Frame: Up to approximately 3 years from enrollment ]
    Time from the first documentation of response (PR or greater) to the first documentation of progressive disease (PD) or death
  • 3. Complete Response (CR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved CR or better according to IMWG Uniform Response Criteria
  • 4. Very good partial response (VGPR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
    Percentage of subjects who achieved VGPR or better according to IMWG Uniform Response Criteria

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:

1. Subjects is ≥ 18 years of age and has an Eastern Cooperative Oncology Group (ECOG)
performance status score of 0, 1 or 2.

2. Relapsed or refractory subjects must have measurable disease and have documented
disease progression during or after their last anti-myeloma regimen.

3. Newly diagnosed subjects must have documented diagnosis with previously untreated
symptomatic multiple myeloma.

4. Females of childbearing potential (FCBP) and male subjects must agree with the
pregnancy prevention plan.

Exclusion Criteria:

1. Subject has a significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study.

2. Subject is unable or unwilling to undergo protocol required thromboembolism
prophylaxis.

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

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, 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
Dana-Farber/Mass General Brigham Cancer Care, Inc
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
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
Institut Paoli Calmette Hematologie
Marseille cedex

France
Hotel Dieu CHU Nantes
Nantes Cedex 01

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

France
CHRU Hopital Bretonneau
Tours cedex

Germany
Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik
Freiburg

Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg

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

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
Hospital Universitario 12 de Octubre
Madrid

Spain
Clinica Universidad de Navarra
Pamplona

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Spain
Hospital Universtario Marques de Valdecilla
Santander

Sponsors and Collaborators

Celgene

Investigators

Study Director: Tsvetan Biyukov, MD 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: March 2, 2021
  • Last Verified: February 2021
  • 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: Neoplasms, Plasma Cell Multiple Myeloma