Phase 1 Study Comparing HLX15-SC and DARZALEX FASPRO with Lenalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

What this Trial Is About

Researchers are evaluating the pharmacokinetic similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC compared to US-DARZALEX FASPRO in patients newly diagnosed with multiple myeloma MM who are not eligible for transplant. This phase 1 randomized, double-blind study aims to understand how these treatments perform when combined with lenalidomide and dexamethasone Rd in this patient group. The study is sponsored by Shanghai Henlius Biotech and focuses on transplant-ineligible MM patients with measurable disease and good performance status. Participants will receive either HLX15-SC or US-DARZALEX FASPRO via subcutaneous injections at a dose of 1800 mg weekly for the first 8 weeks Cycles 1-2 and every two weeks during Weeks 9-16 Cycles 3-4, with each cycle lasting 4 weeks. After completing 4 treatment cycles, based on clinical benefit and participant preference, patients may continue to receive the locally marketed daratumumab subcutaneous formulation combined with Rd for up to 32 weeks or until loss of benefit, death, unacceptable toxicity, withdrawal, or other protocol reasons. Following this period, participants will receive standard care according to local guidelines, which may include daratumumab. Throughout the study, participants will undergo evaluations including pharmacokinetic assessments at 7 days and 16 weeks, safety monitoring through adverse events, vital signs, physical exams, lab tests, and electrocardiograms, as well as immunogenicity and efficacy assessments such as overall response rate and time to response. The total treatment duration is up to 32 weeks, followed by continued standard care. These measures help researchers understand treatment effects, safety, and patient response over time.

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