This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
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.
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, Waldenström macroglobulinemia, or known POEMS syndrome.
focal radiation and/or
European Myeloma Network B.V.
Lead sponsor
Regeneron Pharmaceuticals
Collaborator