Speyer

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults with excess body weight. This phase 3 clinical trial compares weekly injections of NNC0487-0111 against placebo injections, both given under the skin. Participants also follow a reduced-calorie diet and increased physical activity as part of the study. Participants receive subcutaneous injections once a week of either NNC0487-0111 or a placebo. The study uses a randomized, parallel design with quadruple masking to assign treatments by chance. Treatments are given alongside lifestyle changes involving diet and exercise. During the trial, participants will be monitored over 92 weeks with regular assessments including body weight, waist circumference, blood pressure, blood sugar markers, cholesterol levels, and quality of life questionnaires. Safety is evaluated by tracking any adverse events. The primary measurement is the relative change in body weight from week 40 to week 92. The study is sponsored by Novo Nordisk AS and runs until mid-2028.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

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 conducting a prospective, observational study to describe the real-world clinical experience of patients with metastatic castration-resistant prostate cancer mCRPC treated with a combination of olaparib and abiraterone. The study aims to assess clinical outcomes in patients who are either new to novel hormonal agents NHA-naive or have been previously exposed to these agents before starting olaparib plus abiraterone treatment. Patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone will also be documented. Participants will be observed from the start of their olaparib plus abiraterone treatment, with no investigational interventions administered by the study team, reflecting real-world treatment usage. The study plans to enroll patients for up to two years and will follow each patient for one year after the last patient begins treatment. The primary outcome measured is the time to treatment discontinuation within 12 months, along with secondary outcomes such as the time to the first subsequent therapy within 24 months. During the study, participants clinical data, treatment histories, and outcomes will be collected and analyzed. There are no specific study visits or procedures imposed beyond routine clinical care. Safety and treatment adherence will be monitored through observational data. Participants are expected to be involved for the duration of their treatment and follow-up, which may extend to approximately three years from enrollment start to last follow-up.