The aim of the study is to assess the efficacy and safety of the BCD-248 in combination with daratumumab versus the combination of daratumumab, pomalidomide, and dexamethasone in the treatment of relapsed or refractory multiple myeloma. The study will be conducted in a population of male and female subjects aged 18 years and older, with confirmed symptomatic multiple myeloma with measurable disease, who have received one prior line of therapy that included a proteasome inhibitor and lenalidomide and were refractory to lenalidomide, or who have received two or three prior lines of therapy that included a proteasome inhibitor and lenalidomide, with disease progression during or after the last line of therapy.
Signed informed consent form.
Age ≥18 years.
Documented diagnosis of multiple myeloma according to the IMWG criteria.
Measurable disease at screening.
Prior therapy with anti-BCMA or anti-CD3 drugs, pomalidomide.
Refractory to anti-CD38 monoclonal antibodies according to the IMWG criteria.
Use of any investigational products or medical devices within 28 days prior to randomization or planned use of investigational products or medical devices during participation in this study.
Hematopoietic stem cell transplantation - prior to randomization or planned during the study
Parallel
BCD-248 + daratumumab
DrugBCD-248 subcutaneously, daratumumab intravenously
Daratumumab + pomalidomide + dexamethasone
DrugDaratumumab intravenously, pomalidomide per os, dexamethasone per os
Frequency of MRD negativity by flow cytometry at 12 months from the start of therapy
Progression-free survival according to the International Myeloma Working Group (IMWG) criteria
The disease status and treatment efficacy will be analyzed according to the International Myeloma Working Group (IMWG) criteria for response and minimal residual disease assessment in multiple myeloma proposed in 2006 and modified in 2011 and 2016
Overall response rate (at least partial response) according to the IMWG criteria.
Frequency of at least a complete response according to the IMWG criteria.
Frequency of at least a very good partial response according to the IMWG criteria.
Frequency of MRD negativity.