A Phase 3 Randomized Study Comparing 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 who are Transplant Eligible

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

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 Objectives:

To further compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, 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 cilta-cel

Eligibility

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:

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

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

Locations

4100 John R
Detroit, MI 48201
Get Directions

Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices