A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA)

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: * Signed informed consent form. * Age ≥18 years. * Documented diagnosis of multiple myeloma according to the IMWG criteria. * Measurable disease at screening. * At least 1, but not more than 3 prior lines of antimyeloma therapy, including lenalidomide and a proteasome inhibitor. * Documented progression according to the IMWG criteria during or after the last line of therapy. * ECOG score 0-2. * Resolution of symptoms of toxicity on the prior line of therapy. 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: 1. Stable angina pectoris, functional class III-IV. 2. Unstable angina pectoris and/or myocardial infarction within 6 months prior to randomization. 3. Congestive heart failure, NYHA class III-IV. 4. Clinically significant (according to the Investigator) cardiac arrhythmia and conduction disorders that do not respond to the maximum possible antiarrhythmic therapy (therapy must be stable for 4 weeks before the planned start of the study therapy). 5. Moderate to severe asthma, uncontrolled asthma, asthma with forced expiratory volume in 1 second \