NCT04923893Active, not recruitingPhase 3
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
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 743 (actual)
- First submitted
- 10 Jun 2021
- Start date
- 19 Aug 2021
- Primary completion date
- 14 Feb 2029
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT04923893
- EU CT number
- 2023-505850-16-00
- EudraCT number
- 2021-001242-35
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 743
- From 19 Aug 2021 to the primary completion date, 14 Feb 2029
- 128 sites in 26 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
- Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
- Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
- Any therapy that is targeted to B-cell maturation antigen (BCMA)
Other illness
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
- Seropositive for human immunodeficiency virus (HIV)
- Hepatitis B infection
- Hepatitis C infection
Other
- Frailty index of \>=2 according to Myeloma Geriatric Assessment score
- Participant must not require continuous supplemental oxygen
Who the study is looking for
- Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
- Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=)1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
- Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
- Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
- A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
- Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (\>=) 8.0 g/dL (\>=5 millimoles per liter \[mmol/L\]), recombinant human erythropoietin use is permitted; platelets \>=75 \*10\^9/L; absolute lymphocyte count \>=0.3 \*10\^9/L; absolute neutrophil count (ANC) \>=1.0 ×10\^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (\<=) 3.0 \* upper limit of normal (ULN); estimated glomerular filtration rate \>=40 milliliter per minute/1.73 meter square (mL/min/1.73 m\^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin \<=2.0 \* ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=2.0 \* ULN is required)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (128)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Alemán Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Privado Universitario de Córdoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| SCRI CCCIT Ges.m.b.H. Coordinator of this site? Confirm its status | Salzburg | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Royal Brisbane and Womens Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Alfred Health Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Calvary Mater Newcastle Hospital Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Western Sydney Local Health District Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Az St-Jan Brugge-Oostende A.V. Coordinator of this site? Confirm its status | Brugge | Belgium | Active, not recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| IDOR - Regional Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundacao Antonio Prudente A C Camargo Cancer Center Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Hôpital Maisonneuve-Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| University Of Helsinki Coordinator of this site? Confirm its status | Helsinki | Finland | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| University Hospitals Birmingham NHS Trust, Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Bristol Royal Infirmary Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Royal Infirmary Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Royal Marsden NHS Trust Sutton Coordinator of this site? Confirm its status | Surrey | United Kingdom | Unknown status |
| General Hospital of Athens - Alexandra Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Active, not recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Active, not recruiting |
| Hadassah University Hospita Ein Kerem Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center, Tel Hashomer Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya City | Japan | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Seoul St Marys Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Stichting Radboud Universitair Medisch Centrum Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Active, not recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Linkoping University Hospital Region Ostergotland Coordinator of this site? Confirm its status | Linkoping | Sweden | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Active, not recruiting |
| University of Maryland Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Barbara Ann Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| University of Miami Health System Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York Presbyterian-Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| AdventHealth Cancer Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.