Siegburg

Researchers are collecting long-term clinical follow-up data on patients with multiple myeloma who previously took part in therapy studies conducted by the German-Speaking Myeloma Multicenter Group GMMG. The study focuses on tracking overall survival, progression-free survival, and follow-up time to better understand the outcomes of these patients. This national registry gathers comprehensive data from multiple centers in Germany, combining therapy study results with ongoing patient information for scientific research. This is an observational, non-interventional registry that includes retrospective and prospective data on multiple myeloma patients. It incorporates basic patient data, diagnosis details, therapies received, and long-term follow-up information. Patients are observed continuously while receiving standard care until death, loss to follow-up, or withdrawal of consent. Follow-up information is collected every six months until the first disease progression and annually thereafter, using a secure, pseudonymized database with automated data checks. Participants contribute data through routine clinical visits without receiving experimental treatments. The study measures progression-free survival at 5 years and beyond, overall survival, causes of death, and therapy-free intervals after relapse. Data collection includes regular clinical monitoring and centralized oversight to ensure accuracy. This registry supports ongoing research by providing detailed long-term outcome data for multiple myeloma patients, with no limit on sample size and participation expected to continue until the study ends in 2027.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.

Researchers are collecting data to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing the mitral valve through a minimally invasive procedure called transcatheter mitral valve repair. The study focuses on patients with mitral regurgitation to understand how well these devices improve valve function, symptoms, and quality of life in real-world settings after market approval. Participants receive treatment using either the Edwards PASCAL System or the Edwards PASCAL Precision System for transcatheter mitral valve repair. This study is conducted in a postmarket clinical follow-up format, meaning the devices are already approved and are now being further studied to gather safety and effectiveness data over time. During the study, patients will be monitored for major adverse events within 30 days and assessed for changes in mitral regurgitation severity by echocardiography at discharge or 7 days after the procedure. Participants will also attend follow-up visits where functional status and quality of life will be evaluated. The study aims to collect comprehensive safety and effectiveness information over the course of participation, which begins after the mitral valve repair procedure and continues through scheduled follow-ups.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are examining how three major heart conditionsheart failure, coronary artery disease, and atrial fibrillationare currently treated in everyday clinical practice. This observational registry study collects standardized patient data and outcomes to better understand healthcare use and how these diseases and their treatments interact. The study follows guidelines set by the International Consortium for Health Outcomes Measurement to ensure consistent and meaningful tracking of patient experiences and results. The study includes hospitalized patients diagnosed with any of the three heart conditions. There is no specific intervention or treatment assigned by the study instead, it observes how patients are treated in real-world clinical settings. Patients are grouped based on their diagnosis of heart failure, coronary artery disease, or atrial fibrillation. The research team collects data during hospital stays and follows patients over time to monitor health outcomes and treatment effects. Participants will have their health status and outcomes tracked through regular assessments over periods of 6, 12, and 18 months. These evaluations include measurements of all-cause and cardiovascular mortality, rates of hospital readmissions, length of hospital stay, quality of life surveys, side effects related to medications, and adherence to treatments. The study also monitors complications from therapies and the associated costs, providing a detailed view of patient experiences and health outcomes in real-world care over time.