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

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05257083

Run by

Stichting European Myeloma Network

People needed

759

Starts

2023-10-10

Expected to finish

2040-08-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
• 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.

You may not qualify if…

• 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)

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• City of Hope — Duarte, California, United States
• UC San Diego Health Moores Cancer Center — San Diego, California, United States
• University of California San Francisco (UCSF) — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Moffit Cancer Center — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University Of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Mount Sinai Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Montefiore M-E Center — The Bronx, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Sheba medical center — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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