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

ENROLLING
Protocol # :
24-210
Conditions
Multiple Myeloma
Phase
III
Disease Sites
Multiple Myeloma
Principal Investigator
Anderson, Kenneth, C.
Site Research Nurses
Alexander, Sara
Babcock, Elise
Belfiore, Makayla, Blair
Chestnut, Kristin
DiMambro, Paige, E.
Eche-Ugwu, Ijeoma, Julie
Gammon, Marilyn
Giallombardo, Nancy
Logan, Emma, Kristen
Lucia, Megan
Noyes, Sarah, M.
O'Malley, Sarah
Valles, Betsy, J.
Vragovic, Natalia
Weiand, Christine

Trial Description

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.

Eligibility Requirements

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)

24-210