Weiden In Der Oberpfalz

Researchers are evaluating the effectiveness and safety of a new drug combination called Mezigdomide (CC-92480) with bortezomib and dexamethasone (MeziVd) compared to an existing combination of pomalidomide, bortezomib, and dexamethasone (PVd). This study focuses on adults with relapsed or refractory multiple myeloma (RRMM) who have previously received between one and three lines of therapy, including prior lenalidomide treatment. The trial is a Phase 3, randomized, multicenter, open-label study aiming to improve outcomes for this condition. Participants will be assigned to receive either the MeziVd or PVd treatment regimen, with specified doses of each drug given on certain days. The study involves two treatment groups: one receiving mezigdomide, bortezomib, and dexamethasone, and the other receiving pomalidomide, bortezomib, and dexamethasone. Both regimens follow precise dosing schedules as determined by the study protocol. During the study, participants will be monitored regularly for disease progression or death, with the primary outcome being progression-free survival over up to approximately five years from the date of randomization. Ongoing assessments will include evaluations of safety and effectiveness. The total participation time may vary, and researchers will closely follow participants to gather detailed information on treatment responses and adverse effects.

Researchers are investigating the use of ribociclib combined with standard endocrine therapy as a first-line treatment for women with advanced hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer. This phase IV, open-label, single-arm study aims to evaluate the progression-free survival (PFS) and overall survival (OS) rates at 12 months, along with quality of life, treatment toxicity, and comprehensive biomarker analysis to understand patterns of treatment efficacy and resistance. Participants will receive ribociclib orally at a dose of 600 mg daily for 21 consecutive days followed by 7 days off, in 28-day cycles, combined with standard endocrine therapy according to current guidelines and local practice. The study includes extensive biomarker sampling before, during, and after treatment or at disease progression, including blood, tissue, and immune cell analyses to support translational research. During the trial, patients will attend scheduled visits for monitoring and assessments including survival status, safety evaluations, and quality of life questionnaires. Biomarker samples such as circulating tumor DNA and RNA, serum, plasma, and tumor tissue will be collected to evaluate biological changes. The trial plans to enroll 1000 female patients across 75 sites in Germany, with comprehensive follow-up to track treatment outcomes and long-term safety.

This research focuses on evaluating the use of intravenously administered fosfomycin to treat severely infected patients across Europe. It includes those with serious infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis and central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections as permitted by national guidelines. The study is prospective, multicenter, non-interventional, and aims to document both the effectiveness and safety of this treatment. Patients receive fosfomycin treatment according to the national Summary of Product Characteristics (SmPC) guidelines for fosfomycin intravenous use. The study does not involve comparing treatment groups or altering standard care but observes patients receiving fosfomycin in routine clinical settings. There are no specific dosing schedules or additional interventions imposed by the study protocol. During the study, participants are monitored until the end of treatment, which may last up to six months after starting fosfomycin. Researchers evaluate clinical success by assessing whether patients achieve clinical cure or improvement. Safety and outcomes are recorded through clinical observations, with the goal of better understanding fosfomycin's role in treating severe infections.

Researchers are evaluating the safety, performance, and clinical benefits of the Hi-Fatigue G Bone Cement used in total hip and knee replacements. This retrospective study collects survivorship and clinical data to confirm the cement's effectiveness. The study focuses on radiological analysis, implant survivorship, safety, and patient-reported outcome measures over a period extending to five years after surgery. The study involves patients who have undergone primary total knee or hip replacements using Hi-Fatigue G Bone Cement combined with Zimmer Biomet implants. Radiographic evaluations will be performed at multiple time points according to the hospital's standard care, with a primary focus on assessing radiolucent lines around the implant components five years after surgery. Secondary assessments include monitoring adverse events related to the implant or procedure and collecting information about the cementing technique. Participants will be involved through retrospective data collection, including X-rays and clinical scores during interim and final evaluations. The main outcome measure is radiographic assessment from enrollment up to five years post-operation. The study also tracks implant safety, survival, patient-reported outcomes, and any adverse events throughout the follow-up period, ensuring comprehensive long-term monitoring.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.

Researchers are evaluating the effect of adding SBP-101 to the standard treatment of gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for metastatic disease. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival as the primary endpoint, with secondary goals including progression-free survival, radiologic response, and quality of life. The study includes approximately 600 participants and is conducted in phase 2 and phase 3 stages. Participants will be randomly assigned to receive either SBP-101 with gemcitabine and nab-paclitaxel or a placebo with gemcitabine and nab-paclitaxel. SBP-101 is given as a subcutaneous injection and is studied in combination with the chemotherapy drugs nab-paclitaxel and gemcitabine. The study also incorporates a Data Safety Monitoring Board to oversee safety, efficacy, and a planned analysis to determine if the study should continue. During the study, participants will undergo assessments including imaging scans to measure tumor response, quality of life evaluations, and safety monitoring. Overall survival will be tracked from the first dose for up to 100 weeks or until death. The study ensures participants meet specific health and laboratory criteria before enrollment and requires ongoing monitoring to evaluate treatment effects and safety throughout the trial.