ACTIVE_NOT_RECRUITING

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

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Conditions

Multiple MyelomaCellular TherapyCAR-T TherapyBCMA CAR-TNewly Diagnosed Multiple Myeloma

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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

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Official Title

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Quick Facts

Study Start:2023-10-10
Study Completion:2040-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05257083

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. * Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  2. * Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
  3. 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
  4. 2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  5. * ECOG performance status of grade 0 or 1
  6. * Clinical laboratory values within prespecified range.
  1. * Prior treatment with CAR-T therapy directed at any target.
  2. * Any prior BCMA target therapy.
  3. * Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  4. * Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  5. * Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  6. * Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  7. * Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Contacts and Locations

Study Locations (Sites)

University of Arkansas
Little Rock, Arkansas, 72205
United States
City of Hope
Duarte, California, 91010
United States
UC San Diego Health Moores Cancer Center
San Diego, California, 92037
United States
University of California San Francisco (UCSF)
San Francisco, California, 94143
United States
Stanford University
Stanford, California, 94305
United States
Moffitt Cancer Center
Tampa, Florida, 12902
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
University of Chicago
Chicago, Illinois, 60637
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University Of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Center
Detroit, Michigan, 48201
United States
Mayo Clinic Hospital - Rochester
Rochester, Minnesota, 55902
United States
Mount Sinai Medical Venter
New York, New York, 10029
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Montefiore M-E Center
The Bronx, New York, 10461
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Medical College Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Stichting European Myeloma Network

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 Date2023-10-10
Study Completion Date2040-08

Study Record Updates

Study Start Date2023-10-10
Study Completion Date2040-08

Terms related to this study

Keywords Provided by Researchers

  • Cellular Therapy
  • CAR-T Therapy
  • BCMA CAR-T
  • Newly Diagnosed Multiple Myeloma

Additional Relevant MeSH Terms

  • Multiple Myeloma