Summary

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Age: 18 Years and older

Gender: All

Start Date: 10/10/2023

Primary Completion Date (Estimated): 06/01/2033

Study Completion Date (Estimated): 08/01/2040

Accepts Healthy Volunteers: No

Trial Purpose and Description

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel \[cilta-cel\]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT). Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.

* Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or

2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.

* ECOG performance status of grade 0 or 1

* Clinical laboratory values within prespecified range.

Exclusion criteria:

* Prior treatment with CAR-T therapy directed at any target.

* Any prior BCMA target therapy.

* Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids

* Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization

* Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.

* 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)