Siegburg

Researchers are collecting long-term follow-up data on patients with multiple myeloma who took part in therapy studies conducted by the German-Speaking Myeloma Multicenter Group (GMMG). This observational registry study aims to track important outcomes such as overall survival, progression-free survival, and follow-up duration to support scientific research. The registry combines data from previous trials with ongoing patient information for comprehensive analysis. The GMMG Myeloma Registry is a national, observational, and non-interventional study that includes both past and ongoing patient data. It incorporates study databases from various GMMG trials, including the phase 3 GMMG-HD6 trial, which evaluated adding the monoclonal antibody elotuzumab to standard therapy for newly diagnosed multiple myeloma patients eligible for transplant. Data is collected from 35 centers across Germany, with no limit on sample size. Participants will be followed during their standard care treatment until death, loss to follow-up, or withdrawal of consent. Follow-up visits occur every six months until the first disease progression and then yearly afterward. Clinical data is securely stored and regularly monitored with automated checks to ensure accuracy. The main outcome tracked is progression-free survival after five years and through the study's completion, averaging one additional year of observation.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation (ASCT). This phase III clinical trial compares a maintenance treatment combining iberdomide and isatuximab with iberdomide alone. The main goal is to see if adding isatuximab reduces the amount of myeloma cells in the bone marrow after two years. Participants are randomly assigned to one of two groups. One group receives 39 cycles of oral iberdomide, each cycle lasting 29 days. The other group receives the same iberdomide treatment plus subcutaneous isatuximab injections given on specific days during the first three cycles and then monthly from cycle four onward. Both groups receive dexamethasone during the first cycle. The study treatment continues for up to 36 months. During the study, participants undergo regular assessments including bone marrow tests to measure minimal residual disease, blood tests, and questionnaires to evaluate quality of life. Researchers monitor disease progression, response to treatment, and survival over time. The primary outcome is the level of minimal residual disease in the bone marrow 24 months after starting maintenance therapy. Secondary outcomes include progression-free survival, overall survival, response rates, and patient-reported quality of life measures.

This research aims to collect data on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing mitral valve problems, specifically mitral regurgitation and mitral insufficiency. The study focuses on patients who have undergone transcatheter mitral valve repair, evaluating how well these devices improve mitral regurgitation, functional status, and quality of life in a real-world, postmarket setting. Participants will receive treatment using the Edwards PASCAL and PASCAL Precision Transcatheter Valve Repair Systems for mitral valve repair. This study does not involve randomization or comparison groups but follows patients after their valve repair procedure to monitor outcomes. The devices are used according to approved indications after careful patient selection by a Heart Team. During the study, participants will attend follow-up visits where researchers will assess safety by tracking major adverse events within 30 days and evaluate effectiveness through changes in mitral regurgitation severity measured by echocardiography at discharge or seven days post-procedure. The study also monitors improvements in functional status and quality of life over time, requiring participants to complete all scheduled tests and visits to provide comprehensive data on the devices' performance.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are conducting a prospective, non-randomized, open-label, multicenter registry to evaluate the current treatment of three major cardiovascular diseases: heart failure, coronary artery disease, and atrial fibrillation. These diseases significantly contribute to illness and death, especially when they occur together. Although new therapies have been tested in randomized trials, there is limited data confirming their effects in real-world settings using a standardized approach. This study uses standard variable sets defined by the International Consortium for Health Outcomes Measurement (ICHOM) to objectively monitor disease progression and treatment outcomes. The study will build a cardiovascular registry collecting standardized patient information and outcomes based on ICHOM recommendations. It will observe how healthcare is utilized and how diseases and treatments interact in patients with heart failure, coronary artery disease, and atrial fibrillation. No investigational treatments or interventions are assigned, as this is a non-interventional observational study. Participants will be followed to collect clinical and patient-reported data during their inpatient treatment and beyond. The main outcomes measured include all-cause mortality at 6, 12, and 18 months of follow-up. The registry aims to gather comprehensive information on treatment effects and patient outcomes in routine clinical practice to improve understanding and management of these cardiovascular conditions.