Isa-VRD in TIE HRMM

This is a multicenter, prospective, randomized controlled trial designed to compare the quadruplet regimen of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRD) with the standard triplet regimen (VRD) in newly diagnosed, transplant-ineligible patients with high-risk multiple myeloma (HRMM). Primary Hypothesis: The addition of isatuximab to VRD will significantly improve the MRD negativity rate at 12 months compared to VRD alone in HR-NDMM patients. Secondary Hypotheses: Isa-VRD will lead to higher overall response rates (ORR), deeper responses, and improved progression-free survival (PFS) and overall survival (OS). The safety profile of Isa-VRD will be manageable and consistent with the known safety profiles of its individual components.

NCT Number	NCT07334535
Lead Sponsor	Peking Union Medical College Hospital Collaborators: Handan Central Hospital, Inner Mongolia People's Hospital, The Affiliated Hospital of Qingdao University, Hebei Medical University Third Hospital, North China University of Science and Technology, China-Japan Union Hospital, Jilin University, Cangzhou Central Hospital, Yantai Yuhuangding Hospital, Shengjing Hospital, Second Hospital of Shanxi Medical University, Beijing Chao Yang Hospital, Beijing Jishuitan Hospital, Henan Cancer Hospital, Beijing Hospital, Xuanwu Hospital, Beijing, Shandong Cancer Hospital and Institute
Conditions	Multiple Myeloma
Enrollment	117 participants
Start Date	2026-01-30
Primary Completion	2028-07 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-13