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.
Phase:
PHASE4
Details
Lead Sponsor:
Peking Union Medical College Hospital
Collaborators:
Beijing Chao Yang Hospital Beijing Hospital Beijing Jishuitan Hospital Cangzhou Central Hospital China-Japan Union Hospital, Jilin University Handan Central Hospital Hebei Medical University Third Hospital Henan Cancer Hospital Inner Mongolia People's Hospital North China University of Science and Technology Second Hospital of Shanxi Medical University Shandong Cancer Hospital and Institute Shengjing Hospital The Affiliated Hospital of Qingdao University Xuanwu Hospital, Beijing Yantai Yuhuangding Hospital