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).
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 measurable lesion .
Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and/or an absolute plasma cell count of ≥ 2 x 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before randomization.
Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.
Parallel
HLX15-SC-Rd
DrugSubjects will receive 1800 mg HLX15-SC via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
US-DARZALEX FASPRO®-Rd
DrugSubjects will receive 1800 mg US-DARZALEX FASPRO® via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
pharmacokinetic (PK) similarity
Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose.
pharmacokinetic (PK) similarity
The maximum (peak) serum drug concentration (Cmax) after the 1st dose.
pharmacokinetic (PK) similarity
Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose
pharmacokinetic (PK) similarity
The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose
PK characteristics
trough concentration (Ctrough)
PK characteristics
trough concentration at steady state (Ctrough,ss).
Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) terms and frequency of occurrence judged by investigators
Safety: Vital Signs
Vital Signs: including blood pressure (systolic and diastolic; mmHg) , pulse rate (beats/min) measured by hematomanometer
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