Homiel

Researchers are evaluating the safety and effectiveness of BCD-248 combined with daratumumab compared to a combination of daratumumab, pomalidomide, and dexamethasone for treating adults with relapsed or refractory multiple myeloma. This study focuses on participants aged 18 and older who have measurable multiple myeloma and have received previous treatments including a proteasome inhibitor and lenalidomide, specifically those who are refractory to lenalidomide or have had disease progression after prior therapies. Participants will receive either BCD-248 administered under the skin with daratumumab given intravenously, or the combination of daratumumab intravenously with pomalidomide and dexamethasone taken orally. The study is randomized without masking, comparing these two treatment groups in parallel. The intervention period includes monitoring for up to 36 months to assess disease progression and response, with additional long-term evaluations lasting up to 5 years. During the trial, participants will undergo assessments including measuring minimal residual disease using flow cytometry at 12 months, and monitoring progression-free survival per established criteria. Other evaluations include response rates, survival, immune markers, and adverse events over several years. Safety and treatment effects will be closely followed with regular clinical visits and laboratory tests throughout the study duration, which extends until October 2032.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

This research aims to evaluate the real-life effectiveness, safety, and usage patterns of Octapharmas factor VIII FVIII concentratesNuwiq, Octanate, and Wilatein patients with severe haemophilia A who have either never been treated or have had minimal treatment. The study focuses on previously untreated patients, often young children, and minimally treated patients, gathering more data on treatment outcomes and inhibitor development to better understand optimal treatment approaches in routine clinical practice. Participants receive one of the three FVIII concentrates Nuwiq recombinant FVIII, Octanate plasma-derived FVIII, or Wilate plasma-derived FVIII combined with von Willebrand factor. The study observes how these products are used, including dosing and frequency, without altering prescribed treatments. This non-interventional study collects data during routine care to assess product utilization, safety, and effectiveness, including responses to surgical prophylaxis. During the study, researchers monitor participants for breakthrough bleeding rates and any adverse drug reactions over 100 exposure days to assess treatment effectiveness and safety. They also collect information on FVIII dosing and physicians evaluations of surgical prophylaxis effectiveness. The study involves patients of all ages and follows them through their usual clinical visits, with data gathered via observation rather than treatment changes. The study is designed to provide valuable real-world evidence on these FVIII concentrates in severe haemophilia A patients.

This observational, prospective, multi-center study focuses on patients with chronic lymphocytic leukemia CLL in Belarus. It aims to collect real-world data on the use of acalabrutinib in routine clinical practice, addressing important knowledge gaps about its effectiveness, safety, and impact on patient quality of life. All treatment decisions are made by clinicians without study intervention. Participants in this study will be those newly prescribed acalabrutinib monotherapy, meaning they receive acalabrutinib alone without other anti-leukemic drugs around the time of starting treatment. Both treatment-nave and relapsedrefractory CLL patients are eligible. The study involves no comparator or control group and monitors patients over approximately two years with periodic data collection. During the study, researchers will track outcomes such as the time until treatment discontinuation, reasons for stopping treatment, dose changes, treatment interruptions, and any subsequent therapies. Participants are observed without altering their care, with data gathered at regular intervals to assess treatment patterns, safety, and quality of life throughout the study period.

Researchers are evaluating the safety, immune response, and effectiveness of a gene therapy called ANB-002 in adult males with Hemophilia B. This multicenter, open-label study uses a dose-escalation approach combining phase I and II elements to find the best dose of ANB-002, which carries the gene for clotting factor IX FIX. Participants are grouped into four cohorts receiving single intravenous infusions of ANB-002 at increasing doses. Cohorts 1 to 3 involve escalating doses with monitoring for dose-limiting toxicities over 28 days after each infusion. Cohort 4 includes patients with certain antibodies or past hepatitis B infection receiving the highest dose. Decisions to proceed with dosing or enrollment are made by an independent committee. The total participation lasts up to five years. Throughout the study, participants undergo regular assessments including measures of FIX activity, bleeding rates, quality of life questionnaires, and joint health evaluations. Safety monitoring includes tracking adverse reactions during and after treatment. The primary outcomes focus on changes in clotting factor activity and side effects over a five-year period, with secondary outcomes assessing bleeding frequency, treatment use, and well-being.