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.
Inclusion Criteria:
Exclusion Criteria:
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
Plasmapheresis within 14 days prior to randomization.
Administration of a live attenuated vaccine within 28 days prior to randomization.
A history of myelodysplastic syndrome or other malignancies other than multiple myeloma within 5 years prior to screening.
Life-threatening acute complications of the underlying disease.
Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:
Subjects with amyloidosis, POEMS syndrome, plasma cell leukemia
CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
HIV infection, active HBV infection, hepatitis C.
Hypersensitivity, allergy, or intolerance to monoclonal antibodies or any component of BCD-248, daratumumab, pomalidomide, or dexamethasone.
Major surgery within less than 14 days prior to the expected start of the study therapy, incomplete recovery from surgery, or planned surgery during participation in the study.
Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period and within 180 days after receiving the last dose of the IP.
mikhailova@biocad.ru+79110812368
BCD-248 in combination with daratumumab
Daratumumab in combination with pomalidomide and dexamethasone
Homyel, Belarus
Kazan', Russia
Krasnoyarsk, Russia
Saint Petersburg, 190000, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Samara, Russia
Saratov, Russia
Smolensk, Russia
Sochi, Russia
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