Lebach

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating treatments for patients with generalized Mantle Cell Lymphoma in this Phase 3 trial. The study aims to identify one of three treatment approaches as a future standard by comparing failure-free survival, which measures the time from treatment start until stable disease, disease progression, or death. Secondary goals include assessing overall survival, progression-free survival, response rates, safety, and tolerability of the treatments, as well as exploring factors like minimal residual disease and stem cell mobilization. Participants receive one of three treatment plans: the control arm with alternating R-CHOP and R-DHAP chemotherapy followed by autologous stem cell transplantation (ASCT); an experimental arm adding ibrutinib during induction and maintenance with ASCT; or an experimental arm with ibrutinib during induction and maintenance without ASCT. Chemotherapy includes drugs such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, dexamethasone, Ara-C, and cisplatin. Ibrutinib is given in certain induction cycles and as daily maintenance for two years. ASCT conditioning uses specific chemotherapy regimens or total body irradiation depending on the site. During the study, participants undergo regular assessments including imaging, laboratory tests, and evaluations of response and side effects. Researchers monitor failure-free survival up to 10 years, along with secondary outcomes like overall survival, progression-free survival, and safety events. Follow-up includes measuring molecular remission, relapse timing, and quality of life. The total duration includes treatment, maintenance, and long-term observation, with safety and efficacy carefully tracked throughout.

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 focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.