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

NCT05257083 · tracked via the Priya Life Science Germany tracker

Sponsor

Stichting European Myeloma Network

Phase

Phase 3

Started

2023-10-10

Last updated

2026-03-17

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Daratumumab →Bortezomib →Lenalidomide →Dexamethasone →Cilta-cel →Cyclophosphamide →Fludarabine →

Daratumumab: Daratumumab will be administered SC.

Bortezomib: Bortezomib will be administered SC.

Lenalidomide: Lenalidomide will be administered orally.

Dexamethasone: Dexamethasone will be administered orally.

Cilta-cel: Cilta-cel will be administered intravenously

Cyclophosphamide: Cyclophosphamide will be administered intravenously.

Fludarabine: Fludarabine will be administered intravenously.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion 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. Exclusion Criteria: * 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)

Primary outcome measure(s)

Progression free survival (PFS) — up to 10 years ( or 300 PFS events)
Progression free survival is defined as the time from the date of randomization to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first
Sustained MRD-negative CR — up to 24 months
Sustained MRD-negative CR is defined as being MRD negative by bone marrow aspirate, as determined by NGS with a sensitivity of at least 10-5, and meeting the IMWG criteria for CR, and with MRD-negativity status confirmed at a minimum 12 months apart and without any examination showing MRD-positive status or PD in between.

Trial sites (106)

Facility	City	Region
University of Arkansas	Little Rock	Arkansas
City of Hope	Duarte	California
UC San Diego Health Moores Cancer Center	San Diego	California
University of California San Francisco (UCSF)	San Francisco	California
Stanford University	Stanford	California
Moffit Cancer Center	Tampa	Florida
Emory University Hospital	Atlanta	Georgia
University of Chicago	Chicago	Illinois
University of Iowa	Iowa City	Iowa
University Of Maryland Medical Center	Baltimore	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Boston Medical Center	Boston	Massachusetts
Dana-Farber Cancer Institute	Boston	Massachusetts
Karmanos Cancer Center	Detroit	Michigan
Mount Sinai Medical Center	New York	New York
Memorial Sloan-Kettering Cancer Center	New York	New York
University of Rochester	Rochester	New York
Montefiore M-E Center	The Bronx	New York
Levine Cancer Institute	Charlotte	North Carolina
Duke University Medical Center	Durham	North Carolina
Cleveland Clinic	Cleveland	Ohio
The Ohio State University	Columbus	Ohio
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
University of Texas Southwestern Medical Center	Dallas	Texas
University of Virginia	Charlottesville	Virginia
University of Washington Medical	Seattle	Washington
Medical College Wisconsin	Milwaukee	Wisconsin
Princess Alexandra Hospital	Brisbane	Australia
Royal Prince Alfred Hospital	Camperdown	Australia
Royal Brisbane and Womens Hospital	Herston	Australia
Alfred Health	Melbourne	Australia
Austin Hospital	Melbourne	Australia
Peter MacCallum Cancer Centre	Melbourne	Australia
Fiona Stanley Hospital	Murdoch	Australia
Calvary Mater Newcastle Hospital	Waratah	Australia
Westmead Hospital	Westmead	Australia
Jules Bordet Instituut	Anderlecht	Belgium
UZA	Antwerp	Belgium
UZ Gent	Ghent	Belgium
UZ Leuven	Leuven	Belgium

+ 66 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

Other trials for the same condition

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Active, not recruiting

A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and Granulocyte Colony Stimulating Factor (G-CSF) as Compared to Placebo and G-CSF for the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Subjects With Multiple Myeloma (MM) Active, not recruiting

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Active, not recruiting

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05257083 on ClinicalTrials.gov ↗ ← All trials in Germany