Syktyvkar

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

Researchers are evaluating the effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

Researchers are studying the effects of early inclisiran treatment in patients who have experienced a heart attack, specifically STEMI or non-STEMI, in real-world settings in Russia. The study focuses on patients with myocardial infarction and dyslipidemia, aiming to evaluate the clinical outcomes over 12 months after starting inclisiran in addition to basic therapy. Key goals include understanding how this treatment affects lipid profiles, the safety of the therapy, the condition of atherosclerotic plaques using carotid ultrasound, hospitalization rates, and the need for intensive follow-up care. Participants will receive their first inclisiran injection within approximately two weeks after their heart attack. The study observes the effects of this early treatment across a 12-month period, monitoring how inclisiran influences cholesterol levels and cardiovascular health alongside usual care. The research is designed to capture real-world data on inclisiran's impact on patients recovering from myocardial infarction. During the study, participants will be monitored for heart-related events, changes in cholesterol levels, and the status of arterial plaques. Researchers will also track hospital admissions and assess the safety of the treatment. The main outcome measured is the number of patients who experience atherosclerotic cardiovascular disease events within 12 months after starting inclisiran. Overall, the study aims to provide a comprehensive understanding of inclisiran's effects on heart health over one year.

Researchers are evaluating the safety, immune response, and effectiveness of ANB-002, a gene therapy candidate, in male patients with Hemophilia B. This multicenter, open-label study uses a dose-escalation design combining elements of phase I and II to find the best dose. The goal is to understand how the treatment affects blood clotting factor IX (FIX) activity and to monitor for any adverse reactions over five years. The study involves four cohorts receiving single intravenous infusions of ANB-002 at increasing doses. Cohort 1 starts with dose 1, followed by cohorts 2 and 3 with higher doses if no dose-limiting toxicities occur. An independent committee reviews safety data before advancing doses or enrolling more participants. Cohort 4 includes patients with anti-AAV5 antibodies or hepatitis B history and receives the highest dose, dose 3. Participants are followed for five years, with close monitoring for changes in FIX activity and any side effects throughout this period. The study includes assessments to determine the best therapeutic dose and safety profile. Data from the first three cohorts guide decisions for further enrollment and dosing. This long-term follow-up helps evaluate the treatment's lasting impact and safety in patients with Hemophilia B.