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.
Parallel
HLX15-IV
Drugrecombinant anti-CD38 human monoclonal antibody injection
Darzalex
Drugrecombinant anti-CD38 human monoclonal antibody injection
IRC-assessed Week 24 rate of very good partial response (VGPR) or better
the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization.
Investigator-assessed Week 24 rate of VGPR or better
the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization
IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better
percentage of patients achieving VGPR or CR (including sCR) until Week 12, 36 and 48 after the date of randomization
IRC- and investigator-assessed partial response (PR) rate
the percentage of patients achieving PR at any time point after the date of randomization
IRC- and investigator-assessed complete response (CR) rate
the percentage of patients achieving CR at any time point after the date of randomization.
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This trial is not recruiting at the moment. You can still explore other options:
