Clinical Trial

A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma

Not Yet Recruiting Phase 3
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Summary
This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).
Trial Details
NCT Number NCT06895512
Lead Sponsor Shanghai Henlius Biotech
Conditions Newly Diagnosed Multiple Myeloma
Enrollment 386 participants
Start Date 2025-04
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-03-26