About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent form.
Age ≥18 years.
Documented diagnosis of multiple myeloma according to the IMWG criteria.
Measurable disease at screening.
Disqualifiers
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
Trial design
Treatments tested in this trial
- BCD-248 + daratumumab
- Daratumumab + pomalidomide + dexamethasone