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

Ki vehet részt

• 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

Ki nem vehet részt

• 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
• Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study:; Stable angina pectoris, functional class III-IV; Unstable angina pectoris and/or myocardial infarction within 6 months prior to randomization; Congestive heart failure, NYHA class III-IV; 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); Moderate to severe asthma, uncontrolled asthma, asthma with forced expiratory volume in 1 second <50% of predicted normal; Chronic obstructive pulmonary disease with forced expiratory volume in 1 second <50% of predicted normal; A history of angioneurotic edema, severe respiratory failure; Active autoimmune diseases. Patients with type 1 diabetes mellitus and hypothyroidism, requiring only hormone replacement therapy, as well as with skin diseases (vitiligo, alopecia, psoriasis, etc.), which do not require systemic therapy, are allowed to participate; Thromboembolic (deep vein thrombosis, pulmonary embolism) or cerebrovascular (stroke, transient ischemic attack) events within 6 months prior to randomization; Any infection within 14 days prior to randomization that requires systemic etiological therapy or may, in the Investigator's opinion, increase the risk of infectious complications; Any other concomitant disease or condition, which, in the Investigator's opinion, significantly increases the risk of AEs in the study
• 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
• Life-threatening acute complications of the underlying disease
• Subjects with amyloidosis, POEMS syndrome, plasma cell leukemia
• HIV infection, active HBV infection, hepatitis C
• Hypersensitivity, allergy, or intolerance to monoclonal antibodies or any component of BCD-248, daratumumab, pomalidomide, or dexamethasone
• CNS involvement or clinical signs of meningeal involvement of multiple myeloma