A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Korábbi kezelés

• 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, Waldenström 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 C1D1.

Más betegség

• Participants who have uncontrolled intercurrent illness.
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
  • NOTE Other protocol defined inclusion/exclusion criteria apply.

Életkor

• International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.

Egyéb

• Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.

• 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 2.
• Participants must have clinical laboratory values within a prespecified range.