A Study 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 Participants With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507632-20-00
- Lead Sponsor
- European Myeloma Network Stichting
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 723
18 years of age or older, 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 as listed in 5.1.1, page 55 of the protocol.
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 halflives 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy in terms of PFS and sustained MRD-negative CR;Secondary Objective: To further compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy, To characterize the safety of cilta-cel after DVRd therapy followed by lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy, To characterize the PK and pharmacodynamics of cilta-cel, To evaluate the PRO associated with DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy, To determine whether RCL is present in participants that receive ciltacel;Primary end point(s): PFS, Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5
- Secondary Outcome Measures
Name Time Method