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Clinical Trials in the UK / NCT04923893
Active, not recruiting Phase 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

NCT04923893 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2021-08-19
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

BortezomibDexamethasoneLenalidomideCilta-celCyclophosphamideFludarabine

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * Frailty index of \>=2 according to Myeloma Geriatric Assessment score * 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 * 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) * Seropositive for human immunodeficiency virus (HIV) * Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd * Participant must not require continuous supplemental oxygen * Hepatitis B infection * Hepatitis C infection * 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)

Primary outcome measure(s)

Trial sites (136)

FacilityCityRegionStatus
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

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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 NCT04923893 on ClinicalTrials.gov ↗ ← All trials in the UK