Study of Isatuximab with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant in China

What this Trial Is About

This research aims to evaluate the effectiveness and safety of the Isa-VRd regimen, combining Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone, in patients newly diagnosed with multiple myeloma who are not eligible for transplant. The study focuses on real-world use in China with a planned enrollment of 333 patients aged 18 and older. It explores important outcomes like complete response rates and minimal residual disease negativity. Participants will receive Isatuximab intravenously in an induction phase lasting 8 cycles of 4 weeks each about 32 weeks total. Dosing schedules include weekly and biweekly treatments depending on the cycle, along with subcutaneous Bortezomib injections, oral Lenalidomide daily with dose adjustments based on kidney function, and oral Dexamethasone on specific days. After induction, the treatment regimen may be adjusted by investigators, followed by a maintenance phase and long-term follow-up. During the study, participants will undergo regular assessments to monitor treatment effectiveness, including response evaluations each cycle and periodic minimal residual disease testing at months 8, 14, 20, and 26. Safety monitoring includes tracking adverse events throughout treatment and follow-up, which lasts up to 24 months. The study records additional outcomes such as survival rates and time to disease progression to better understand the treatments impact.

Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients