ACTIVE_NOT_RECRUITING

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Official Title

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

Quick Facts

Study Start:2022-06-23
Study Completion:2032-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04975997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 035
Hot Springs, Arkansas, 71913
United States
Local Institution - 641
Cerritos, California, 90703-2679
United States
Local Institution - 681
Fountain Valley, California, 92708
United States
Local Institution - 047
Los Angeles, California, 90033
United States
Local Institution - 684
Newport, California, 92663
United States
Local Institution - 033
New Haven, Connecticut, 06511
United States
Local Institution - 029
Fort Myers, Florida, 33901
United States
Local Institution - 693
Ocala, Florida, 34471-6950
United States
Local Institution - 028
Saint Petersburg, Florida, 33705
United States
Local Institution - 045
Tamarac, Florida, 33321-2909
United States
Local Institution - 034
West Palm Beach, Florida, 33401
United States
Local Institution - 685
Weston, Florida, 33331-3609
United States
Local Institution - 018
Atlanta, Georgia, 30322
United States
Local Institution - 640
Elk Grove Village, Illinois, 60007-3363
United States
Local Institution - 697
Dyer, Indiana, 46311-1596
United States
Local Institution - 040
Louisville, Kentucky, 40207
United States
Local Institution - 041
Alexandria, Louisiana, 71301-3841
United States
Local Institution - 682
Baton Rouge, Louisiana, 70808-4300
United States
Local Institution - 027
Baton Rouge, Louisiana, 70809-3675
United States
Local Institution - 698
Baltimore, Maryland, 21204-6826
United States
Local Institution - 014
Bethesda, Maryland, 20817
United States
Local Institution - 688
Columbia, Maryland, 21044-3128
United States
Local Institution - 010
Boston, Massachusetts, 02215
United States
Local Institution - 009
Worcester, Massachusetts, 01655
United States
Local Institution - 645
Burnsville, Minnesota, 55337-6749
United States
Local Institution - 031
Kansas City, Missouri, 64132
United States
Local Institution - 046
Billings, Montana, 59102-6746
United States
Local Institution - 015
Summit, New Jersey, 07901
United States
Local Institution - 691
New York, New York, 10016
United States
Local Institution - 039
Durham, North Carolina, 27705
United States
Local Institution - 038
Cincinnati, Ohio, 45220
United States
Local Institution - 037
Cleveland, Ohio, 44109
United States
Local Institution - 008
Cleveland, Ohio, 44195
United States
Local Institution - 036
Columbus, Ohio, 43214
United States
Local Institution - 680
Tulsa, Oklahoma, 74146-6236
United States
Local Institution - 043
Portland, Oregon, 97239
United States
Local Institution - 030
Chattanooga, Tennessee, 37404
United States
Local Institution - 021
Nashville, Tennessee, 37203
United States
Local Institution - 687
Austin, Texas, 78705-1165
United States
Local Institution - 695
Houston, Texas, 77025
United States
Local Institution - 642
Newport News, Virginia, 23606-3069
United States
Local Institution - 643
Roanoke, Virginia, 24014-2419
United States
Local Institution - 025
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23
Study Completion Date2032-06-25

Study Record Updates

Study Start Date2022-06-23
Study Completion Date2032-06-25

Terms related to this study

Keywords Provided by Researchers

  • Iberdomide
  • CC-220
  • Daratumumab
  • Darzalex Faspro
  • Bortezomib
  • Velcade
  • Dexamethasone
  • MM
  • Multiple Myeloma
  • RRMM
  • CELMoD
  • Cereblon Modulators

Additional Relevant MeSH Terms

  • Multiple Myeloma