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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

Name: 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 — clinical trial record (NCT06895512)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorShanghai Henlius Biotech

Started2025-04

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Shanghai Henlius Biotech

56 trials monitored

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Multiple Myeloma

1,228 trials monitored

See 75 trials at risk

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