A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally mar

Trial Details

NCT ID
NCT07477587
Phase
PHASE1
Sponsor
Shanghai Henlius Biotech
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • HLX15-SC-Rd
  • US-DARZALEX FASPRO®-Rd
Locations (sample)
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Ocala, Florida, United States|29.1872,-82.14009
  • Covington, Louisiana, United States|30.47549,-90.10042
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Age ≥ 18 years at the time of signing the informed consent form (ICF).
  • Body mass index (BMI): 18.5 kg/m2 ≤ BMI \< 28 kg/m2.
  • Subjects must participate voluntarily, understand the study, and sign the ICF.
  • Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measu…

For full eligibility, visit ClinicalTrials.gov.

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