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NOT YET RECRUITING
NCT06895512
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

HLX15-IV

recombinant anti-CD38 human monoclonal antibody injection

DRUG

Darzalex

recombinant anti-CD38 human monoclonal antibody injection

Locations (1)

Zhongshan hospital, Shanghai

Shanghai, Shanghai Municipality, China