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
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)
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.
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.
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