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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
Sponsor: Shanghai Henlius Biotech
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).
Official title: A Randomized, Double-blind, Parallel-controlled, Multicenter, Phase III 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
386
Start Date
2025-04
Completion Date
2027-07
Last Updated
2025-03-26
Healthy Volunteers
No
Conditions
Interventions
HLX15-IV
recombinant anti-CD38 human monoclonal antibody injection
Darzalex
recombinant anti-CD38 human monoclonal antibody injection
Locations (1)
Zhongshan hospital, Shanghai
Shanghai, Shanghai Municipality, China