Reggio

Researchers are evaluating an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation. The study focuses on comparing the effects and safety of linvoseltamab against the standard treatment in this group of patients. This is a Phase 3 randomized, open-label study involving transplant-ineligible multiple myeloma patients. Participants will receive either linvoseltamab according to the study protocol or a combination of daratumumab, lenalidomide, and dexamethasone as the standard treatment. The trial includes an induction phase with daratumumab, lenalidomide, and dexamethasone followed by treatment with linvoseltamab or continuation of the standard therapy. All drugs are administered as directed by the study protocol. During the study, participants will be closely monitored for disease response and safety over a period of up to 11 years. Researchers will measure outcomes such as minimal residual disease status, progression-free survival based on specific criteria, and treatment response assessed by blinded independent review. Safety and long-term effects will also be evaluated throughout the study duration.

Researchers are conducting a multicenter, randomized, open-label Phase 3 study to evaluate treatments for participants with newly diagnosed multiple myeloma. The study compares teclistamab combined with lenalidomide and teclistamab alone against lenalidomide alone when used as maintenance therapy following autologous stem cell transplant. The goal is to assess the benefits of these therapies in maintaining disease control after transplant. Participants will receive one of three maintenance therapies: teclistamab given by subcutaneous injection with lenalidomide taken orally, teclistamab alone by subcutaneous injection, or lenalidomide alone taken orally. Treatment begins after autologous stem cell transplant and continues as maintenance. Each group receives treatment according to the assigned therapy to monitor effectiveness and safety. During the study, participants will be regularly evaluated through clinical assessments and laboratory tests to monitor disease progression and response. The main outcomes measured include progression-free survival up to approximately 8 years and the rate of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also monitored throughout the trial to ensure participant well-being.