Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Stichting European Myeloma Network
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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, Lenalidomid...
Detailed 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. J...
Eligibility Criteria
Inclusion
- 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.
- ECOG performance status of grade 0 or 1
- Clinical laboratory values within prespecified range.
Exclusion
- 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)
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2040
Estimated Enrollment :
759 Patients enrolled
Trial Details
Trial ID
NCT05257083
Start Date
October 10 2023
End Date
August 1 2040
Last Update
December 18 2025
Active Locations (105)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72205
2
City of Hope
Duarte, California, United States, 91010
3
UC San Diego Health Moores Cancer Center
San Diego, California, United States, 92037
4
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143