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

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003284-10-SE
• Lead Sponsor: Stichting European Myeloma Network (EMN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-11
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified