Phase 3 Study of Teclistamab with Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

What this Trial Is About

Researchers are evaluating the effectiveness of teclistamab combined with lenalidomide and teclistamab alone compared to lenalidomide alone as maintenance therapy in participants with newly diagnosed multiple myeloma. This Phase 3, multicenter, randomized, open-label study focuses on patients who have undergone autologous stem cell transplant. The goal is to assess the benefits of these treatments in preventing disease progression after transplant. Participants will be randomly assigned to one of three groups teclistamab with lenalidomide, teclistamab alone, or lenalidomide alone. Teclistamab is given as a subcutaneous injection, while lenalidomide is taken orally. The treatments are administered as maintenance therapy following stem cell transplantation. During the study, participants will be monitored for disease progression and survival for up to approximately eight years. Researchers will assess progression-free survival and the rate of complete response with no detectable minimal residual disease at 12 months. Quality of life, symptom impact, and patient-reported toxicities will also be evaluated through questionnaires. Safety and overall survival will be tracked throughout the study period.

Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation