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Isa-VRD in TIE HRMM

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 202 wordsv2 See this version in full on ClinicalTrials.gov ↗
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov