drugset / Trial / NCT06895512

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

NCT06895512

Phase 3 Not yet recruiting 386 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2025-04
Primary completion
2027-07
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daratumumab Monoclonal antibody
Subject HLX15-IV Monoclonal antibody

Indications