U.S., Jan. 13 -- ClinicalTrials.gov registry received information related to the study (NCT07334535) titled 'Isa-VRD in TIE HRMM' on Jan. 03.
Brief Summary: 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 progressi...