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

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.

Conditions

Multiple Myeloma
Talk to us

Related Conditions:

Multiple Myeloma

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Little Rock

University of Arkansas, Little Rock, Arkansas, United States, 72205

Duarte

City of Hope, Duarte, California, United States, 91010

San Diego

UC San Diego Health Moores Cancer Center, San Diego, California, United States, 92037

San Francisco

University of California San Francisco (UCSF), San Francisco, California, United States, 94143

Stanford

Stanford University, Stanford, California, United States, 94305

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 12902

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Kansas City

The University of Kansas Cancer Center, Kansas City, Kansas, United States, 66160

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  • * Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
  • 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
  • 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.
  • * ECOG performance status of grade 0 or 1
  • * Clinical laboratory values within prespecified range.
  • * Prior treatment with CAR-T therapy directed at any target.
  • * Any prior BCMA target therapy.
  • * Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • * Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  • * Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  • * Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • * Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stichting European Myeloma Network,

Study Record Dates

2040-08