Kaliningrad

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

Researchers are examining how the location of colorectal cancer tumors affects outcomes after surgery. This study looks at risks such as death, leakage at the surgical connection, early and late complications, cancer recurrence, and survival rates specific to cancer over several years after surgery. The study focuses on patients with colorectal cancer undergoing surgery and aims to understand how tumor location impacts treatment results. Participants receive different types of surgical procedures depending on where their tumor is located. These include removal of parts of the colon or rectum, such as right or left hemicolectomy, sigmoid colon resection, anterior or low anterior resection of the rectum, abdominoperineal resection, or total colectomy for multiple tumors. Each surgery is selected based on the tumors position from the cecum to the rectum or if multiple primary tumors are present. Throughout the study, researchers will monitor participants for surgical complications within 30 days, leakage rates at the surgical join after 3 months, and mortality along with cancer recurrence and survival up to 3 years post-surgery. Patients will attend study visits to provide data for these outcomes, including cancer-specific and recurrence-free survival. The study is observational and follows patients over this period to collect detailed safety and effectiveness information about colorectal cancer surgeries.

This research aims to evaluate the effectiveness and safety of different doses of the drug Grammidin with anesthetic, delivered as a metered dose topical spray, for treating acute infectious and inflammatory diseases of the pharynx. These conditions include acute pharyngitis, nasopharyngitis, and exacerbation of chronic pharyngitis. The study compares Grammidin spray with Septolete Total lozenges as an active comparator in a Phase 2 randomized trial. Participants are assigned to one of three groups one group receives Grammidin spray with 2 sprays every 6 hours three times daily for 7 days, another group receives Grammidin spray with 4 sprays on the same schedule, and the third group takes Septolete Total lozenges 1 lozenge every 6 hours, up to 3 lozenges daily for 7 days. Treatments are taken under fed conditions. The study is open-label, multicenter, and parallel-group. During the 8-day study period, participants attend visits on Day 1, Day 5, and Day 8 for assessments including sore throat severity measured by Visual Analog Scale VAS and the Clinical Symptom Severity Scale. Researchers monitor clinical symptoms, inflammation signs, and intoxication syndrome. Safety is evaluated through recording adverse events, vital signs, physical examinations, and multiple laboratory tests such as blood counts, blood chemistry, and urinalysis. The study tracks treatment adherence and overall patient outcomes over the three visits.

Researchers are evaluating the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients aged 18 to 75 years. This multicenter, double-blind, placebo-controlled, randomized clinical trial focuses on adults experiencing symptoms within 48 hours of disease onset during the seasonal peak of acute respiratory viral infections. The study aims to compare Raphamin against placebo in improving symptoms and quality of life. Participants will be randomly assigned to one of two groups at the first visit. One group receives Raphamin tablets dissolved in the mouth following a specific dosing schedule over 5 days, starting with multiple doses on day 1 and three times daily thereafter. The other group receives a placebo on the same schedule. The study includes a treatment period of 5 days and follow-up visits up to 14 days. Participants will attend three visits on days 1, 4, and 7, either at a medical center or at home, with a phone visit on day 14. They will complete symptom severity scales and quality of life questionnaires, record daily temperature and symptoms in an electronic diary, and report any worsening condition or adverse events. Researchers will monitor symptom improvement, safety, antibiotic use, hospitalizations, and vital signs throughout the study and follow-up period.

This research aims to evaluate the effectiveness and safety of intra-arterial intrathrombus administration of recombinant non-immunogenic staphylokinase Fortelyzin4 compared to surgery in patients experiencing acute limb ischemia ALI. ALI is a serious condition with high mortality, and this study focuses on a thrombolytic treatment that targets clot breakdown directly within affected arteries. The trial builds on previous studies showing promising results with this staphylokinase in heart attacks and strokes, assessing its role specifically in ALI. Participants will be randomly assigned to receive either Fortelyzin4 delivered directly into the blood clot via a catheter or surgical treatment including endovascular intervention, open surgery, or bypass surgery based on current national guidelines. The Fortelyzin4 treatment involves an initial bolus injection followed by a continuous infusion over ten hours through a perforated multihole catheter. Surgery will be conducted according to standard practice. This is an open-label, multicenter Phase 3 trial. During the study, participants will be monitored for 30 days after randomization to assess outcomes, focusing primarily on the number of patients who avoid amputation. Assessments will include safety monitoring for bleeding and other adverse events. Informed consent and contraception adherence are required, and ongoing patient evaluations will help researchers understand the comparative benefits and risks of these treatment approaches for ALI.