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

Phase 3

Recruiting

• Conditions: Kahler's disease; Multiple Myeloma; 10035227

• Registration Number: NL-OMON56455
• Lead Sponsor: European Myeloma Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

-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.

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 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
• Study Design: Not specified