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).
Capable to understand and sign the ICF.
Patients aged ≥ 18 years .
Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
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 or POEMS syndrome .
Patient has prior or current systemic therapy or ASCT for MM before randomization.
Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.