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
Condition(s) studied
Investigational drug(s) / intervention(s)
Bortezomib: Bortezomib will be administered SC.
Dexamethasone: Dexamethasone will be administered orally.
Lenalidomide: Lenalidomide will be administered orally.
Cilta-cel: Cilta-cel infusion will be administered.
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 Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Up to 4 years and 5 months
Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Trial sites (136)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF | San Francisco | California | |
| Yale Cancer Center | New Haven | Connecticut | |
| University of Miami Health System | Miami | Florida | |
| AdventHealth Cancer Institute | Orlando | Florida | |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | |
| University of Kentucky | Lexington | Kentucky | |
| Norton Cancer Institute | Louisville | Kentucky | |
| University Of Maryland Medical Center | Baltimore | Maryland | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| Henry Ford Cancer Institute | Detroit | Michigan | |
| Columbia University Medical Center | New York | New York | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| New York Presbyterian-Weill Cornell Medical College | New York | New York | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| University of Virginia | Charlottesville | Virginia | |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | |
| Hospital Aleman | Buenos Aires | Argentina | |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | |
| Hospital Privado Universitario De Cordoba | Córdoba | Argentina | |
| Royal Prince Alfred Hospital | Camperdown | Australia | |
| St Vincents Hospital Melbourne | Fitzroy | Australia | |
| Austin Health | Heidelberg | Australia | |
| Royal Brisbane and Womens Hospital | Herston | Australia | |
| Alfred Health | Melbourne | Australia | |
| Peter MacCallum Cancer Centre | Melbourne | Australia | |
| Fiona Stanley Hospital | Murdoch | Australia | |
| Calvary Mater Newcastle Hospital | Waratah | Australia | |
| Western Sydney Local Health District | Westmead | Australia | |
| Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie | Graz | Austria | |
| Krankenhaus der Elisabethinen Linz | Linz | Austria | |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | Austria | |
| Medical University of Vienna Universitatsklinik fur Innere Medizin I | Vienna | Austria | |
| Universitair Ziekenhuis - Antwerpen | Antwerp | Belgium | |
| AZ St.-Jan Brugge-Oostende AV | Bruges | Belgium | |
| UZ Gent | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Liège | Belgium |
+ 96 more sites — see the full list on the official registry below.
On this site
📄 Revlimid (lenalidomide) drug profile →More Janssen Research & Development, LLC trials in Sweden
Other trials for the same condition
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 NCT04923893 on ClinicalTrials.gov ↗ ← All trials in Sweden