Clinical Trials in the Netherlands / NCT05257083
Active, not recruiting
Phase 3
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 Netherlands tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
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
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 | Status |
|---|---|---|---|
| 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.
More Stichting European Myeloma Network trials in the Netherlands
Other trials for the same condition
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 the Netherlands