Study of Teclistamab and Daratumumab Combination Treatment for Newly Diagnosed Multiple Myeloma with Light Chain Amyloidosis

What this Trial Is About

Researchers are evaluating the combination of teclistamab and daratumumab Tec-Dara as a treatment for patients who have newly diagnosed multiple myeloma along with concurrent light chain amyloidosis MMAL. The study aims to determine if Tec-Dara improves the 1-year progression-free survival rate compared to historical data and to assess various hematologic and organ responses. It also seeks to understand the safety and medical issues participants might experience during treatment. Participants in this study will receive subcutaneous injections of teclistamab with a step-up dosing schedule starting at 0.06 mgkg and increasing to 3.0 mgkg over several cycles. Daratumumab will also be given by subcutaneous injection at a dose of 1800 mg on a set schedule that changes over the course of up to 24 cycles, which may last about two years. Treatment will continue until disease progression, unacceptable side effects, or the completion of 24 cycles. Throughout the trial, participants will undergo disease assessments every 28 days, including laboratory tests to evaluate both hematologic and organ responses. Bone marrow samples will also be collected for detailed analysis such as minimal residual disease MRD and RNA sequencing. The study will measure outcomes like progression-free survival, response rates, duration of response, and treatment-related side effects over a period of up to three years.

A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).