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 - CARTITUDE-6

European Myeloma Network0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-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.

•-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)

发起方

European Myeloma Network