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 Who

• Status: Recruiting
• Trial end date: 2034-01-17
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Bortezomib; Cyclophosphamide; Dexamethasone; Fludarabine; Lenalidomide

Criteria

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 (beta-human chorionic gonadotropin) tests prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd). The first test must be within 10 to 14 days prior to the start of VRd

• Clinical laboratory values meeting the following criteria during the screening phase:

hemoglobin greater than (>)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 defined as (anti-hepatitis C virus [HCV] antibody positive or detectable HCV- ribonucleic acid [RNA]) or known to have a history of hepatitis C

• 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)