ASH 2023 | Investigating linvoseltamab monotherapy in SMM: the LINKER-SMM1 trial

It was a poster, a trial-in-progress abstract, so this is just disclosing the design of a study that we are going to start within the Spanish Myeloma Group that is investigating linvoseltamab therapy for the treatment of high-risk smoldering multiple myeloma patients. So we know that this group of patients with high-risk smoldering multiple myeloma have a short time until progression to active disease, and that lenalidomide in combination with dexamethasone has shown to be effective in delaying progression to multiple myeloma. So the hypothesis behind conducting this study is that a fixed duration of therapy with a BCMA bispecific antibody, linvoseltamab, will prevent the progression of high-risk smoldering myeloma patients to multiple myeloma, and this is the aim of this study. So the study aims to enroll 50 patients with two portions of the study: a part one that is looking for the recommended dose and a part two that is looking for preliminary efficacy. So in the part one we will enroll a few patients to evaluate safety, and then we will expand the trial to get an idea of the preliminary efficacy of the linvoseltamab monotherapy. So these are the two main objectives of this study.