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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Daratumumab | Monoclonal antibody | — | — |
| Subject | HLX15-IV | Monoclonal antibody | — | — |