The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.
Signed informed consent form.
Age ≥ 18 years at the time of signing of the informed consent form.
Documented diagnosis of multiple myeloma according to IMWG criteria
M-protein in serum ≥ 1.0 g/dL (10 g/L) or in 24-hour urine ≥ 200 mg; or
Prior treatment with daratumumab or other anti-CD38 therapy.
Prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids
Autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization.
Allogeneic hematopoietic stem cell transplantation, regardless of timing.
Parallel
BCD-264
DrugIV, 16 mg/kg
Darzalex
DrugIV, 16 mg/kg
Overall response rate according to IMWG (International Myeloma Working Group) criteria
Stringent complete response rate according to IMWG criteria
Complete response (CR) rate according to IMWG criteria
Very good partial response (VGPR) rate according to IMWG criteria
Duration of response
Incidence and characteristics of adverse events
Proportion of subjects with BAbs/Nabs
Time to BAb/NAb development
AUC0-168
