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
Study ID
NCT06895512
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX15-IV — DRUG
    recombinant anti-CD38 human monoclonal antibody injection
  • Darzalex — DRUG
    recombinant anti-CD38 human monoclonal antibody injection

Study Details

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).

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX15-IV-Rd
    HLX15-IV in combination with Lenalidomide-Dexamethasone (Rd)
  • Active Comparator: DARZALEX-Rd
    DARZALEX in combination with Lenalidomide-Dexamethasone (Rd)

Primary Outcome Measure

IRC-assessed Week 24 rate of very good partial response (VGPR) or better [ Time Frame: 24 weeks ]

Related Studies