BCD-248-3/AMMADINA "An open-label, randomized, Phase III trial evaluating the efficacy and safety of BCD-248 in combination with daratumumab vs. daratumumab, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma."Throughout the BCD-248-3/AMMADINA clinical trial, the efficacy and safety of BCD-248 in combination with daratumumab will be evaluated compared with the combination of daratumumab, pomalidomide, and dexamethasone as therapy for relapsed or refractory multiple myeloma in participants who:
Are at least 18 years of age at the time of signing the informed consent form;
Have a documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria1;
Meet the following criteria at screening2:
Serum M-protein ≥ 1.0 g/dL (10 g/L); or
M-protein in 24-hour urine ≥ 200 mg/day; or
Serum “involved” FLC3 level ≥ 10 mg/dL (100 mg/L) and an abnormal κ/λ FLC ratio;
Have received at least 1 but no more than 3 prior lines of therapy for multiple myeloma, including lenalidomide and a proteasome inhibitor. The participant must have completed 1 or more cycles for each line of therapy, unless progression was the best response for that line;
Have documentary evidence of disease progression per IMWG criteria (as assessed by the investigator) during or after the last line of therapy;
Have an ECOG performance status4 of 0–2;
Have laboratory test results consistent with adequate organ and system function.
The Clinical Study Protocol requires a bone marrow aspiration to be performed as part of the study.
This clinical trial includes exclusion criteria (criteria that disqualify an individual from participation in this specific trial), and the investigator will provide the full list to potential participants. Specifically, the exclusion criteria are:
Prior anti-BCMA5 or anti-CD36 therapy;
Prior therapy with pomalidomide;
Other anticancer therapy, including targeted therapy, epigenetic therapy, immunotherapy, radiation therapy, cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, glucocorticoids, during the periods specified in the Clinical Study Protocol prior to randomization;
Autologous hematopoietic stem cell transplantation within 12 weeks prior to randomization or allogeneic hematopoietic stem cell transplantation within 24 months prior to randomization7;
Planned hematopoietic stem cell transplantation prior to disease progression while participating in a clinical study;
A history of myelodysplastic syndrome or other malignancies, other than multiple myeloma, within 5 years prior to the start of screening, with the exception of squamous cell and basal cell skin cancers, carcinoma in situ of the cervix or breast, bladder cancer without invasion into the muscle layer that are considered to have been radically cured, or other malignancies that, in the opinion of the investigator, are considered adequately treated, do not require active therapy, and pose a minimal risk of recurrence;
Comorbidities and/or concomitant conditions that significantly increase the risk of adverse events during the study:
Stable angina, functional class III–IV;
Unstable angina and/or myocardial infarction less than 6 months prior to the anticipated start of the investigational therapy;
Chronic heart failure, NYHA class III–IV8;
The presence of clinically significant heart rhythm and conduction abnormalities, as determined by the investigator, that do not respond to the maximum possible antiarrhythmic therapy (the therapy must be stable for 4 weeks prior to the anticipated start of investigational therapy);
Moderate-to-severe bronchial asthma, uncontrolled asthma, or asthma with a forced expiratory volume in 1 second (FEV₁) < 50% of predicted values;
Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV₁) < 50% of predicted values;
History of angioedema, severe respiratory failure;
Active autoimmune diseases (subjects with type 1 diabetes and hypothyroidism requiring only hormone replacement therapy, as well as those with skin conditions (vitiligo, alopecia, or psoriasis) that do not require systemic therapy);
Thromboembolic (deep vein thrombosis, pulmonary embolism) or cerebrovascular (stroke, transient ischemic attack) events within 6 months prior to randomization;
Multiple myeloma involving the central nervous system and/or clinical signs of meningeal involvement;
HIV infection, active viral hepatitis B, or active hepatitis C;
Major surgical procedures performed less than 14 days prior to the anticipated date of the investigational therapy, incomplete recovery from a previous surgical procedure, or planned surgical procedures while participating in the clinical trial.
The BCD-248-3/AMMADINA clinical trial is being conducted at study centers in various cities across the Russian Federation and the Republic of Belarus, including Moscow, St. Petersburg, Samara, Barnaul, Omsk, Sochi, Chelyabinsk, Rostov-on-Don, Ufa, Krasnoyarsk, Smolensk, Novosibirsk, Syktyvkar, Veliky Novgorod, Kazan, Saratov, Tomsk, Irkutsk, as well as Minsk, Vitebsk, and Gomel.
You can ask questions about participating in the clinical trial, including requesting contact information for the study centers, using the dedicated form on the website ct.biocad.ru.
The investigator will explain the other eligibility criteria and contraindications for participation in this clinical trial to the potential participant. A potential participant should review the complete information about the study and consult with the investigator and/or their treating physician.
The Permit of the Ministry of Health of the Russian Federation for this clinical trial, No. 176, dated April 30, 2026, and the list of approved study sites have been published in the State Register of Medicines.
The Resolution of the Ministry of Health of the Republic of Belarus to conduct this clinical trial, No. 141/677/2026 dated June 8, 2026, and the list of approved study sites in the Republic of Belarus have been published in the State Register of Clinical Trials of the Republic of Belarus.
IMWG — International Myeloma Working Group.
Screening is a specific period of time intended to evaluate a subject’s eligibility to participate in a clinical trial based on eligibility criteria and the results of diagnostic procedures and specialist consultations.
FLC — free light chains.
ECOG — a scale that describes a patient's performance status in terms of their ability to care for themselves, daily activities, and physical activity.
BCMA — B-cell maturation antigen, which is a cell membrane protein involved in the differentiation and maturation of B-lymphocytes in plasma cells.
CD3 (cluster of differentiation 3) — protein complex on the surface of T-lymphocytes.
Randomization — the random assignment of clinical trial subjects to one of the treatment groups.
NYHA — the New York Heart Association's classification of the severity of chronic heart failure.