A Randomized, Open-Label, Controlled Phase 3 Study Comparing Daratumumab, Lenalidomide and Dexamethasone Induction followed by Linvoseltamab Versus continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

未提供0 个研究点目标入组 60 人开始时间: 待定

适应症

试验速览

暂无简介。

•Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
•Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
•Participants must have measurable disease as defined in the protocol.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
•Participants must have clinical laboratory values within a prespecified range.

•International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
•Participants who defer transplant due to personal preference.
•Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenstrom macroglobulinemia, or known POEMS syndrome.
•Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:
•focal radiation and/or
•a short course of corticosteroids as defined in the protocol.
•Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
•Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D
•Participants who have uncontrolled intercurrent illness.
•Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
•History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.

发起方

未提供