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 marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).

NCT Number	NCT07477587
Lead Sponsor	Shanghai Henlius Biotech
Conditions	Multiple Myeloma (MM)
Enrollment	258 participants
Start Date	2026-05-27
Primary Completion	2027-05-25 (estimated)
Study Completion	2028-02-22 (estimated)
Updated on ClinicalTrials.gov	2026-05-22