Varese

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients usual care, and participation duration may vary depending on individual follow-up.

Researchers are conducting an observational, multicenter, prospective study involving adults with severe eosinophilic asthma who are treated with benralizumab. The study aims to evaluate how often patients achieve partial or complete clinical remission, as defined by SANI criteria. Additionally, it seeks to gather more evidence on benralizumabs immunological effects and its role in asthma treatment, while also consolidating long-term safety data. Participants will be treated with benralizumab 30mg administered subcutaneously according to the approved label and local reimbursement rules. The study will observe patients who have started or plan to start benralizumab within 7 days of enrollment. This real-life study does not involve experimental dosing but follows patients receiving benralizumab in routine clinical practice to collect important data over time. During the study, participants will undergo regular assessments for up to 24 months. Researchers will measure clinical remission rates at multiple time points and monitor asthma control using questionnaires like the Asthma Control Test ACT and Asthma Control Questionnaire ACQ. Lung function tests such as FEV1 and FVC will be evaluated before and after bronchodilator use. Medication use and exacerbation rates will also be tracked. The study focuses on understanding benralizumabs effects and safety in a real-world setting over a long period.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the safety and tolerability of an investigational drug called elritercept, both alone and in combination with the JAK inhibitor ruxolitinib, in adults with myelofibrosis MF. The study also aims to understand how elritercept affects the signs and symptoms of MF, how the body processes the drug, and its effects on anemia when used with or without ruxolitinib. This is a Phase 2 open-label study focusing on participants with anemia related to MF.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating how well guselkumab works to improve symptoms of psoriatic arthritis, an inflammatory joint disease affecting people with psoriasis, by using musculoskeletal ultrasound MSUS in a real-world setting. This observational study aims to collect data from routine clinical practice to better understand treatment effects in participants who have active psoriatic arthritis and meet specific clinical and imaging criteria. Participants with a confirmed diagnosis of psoriatic arthritis who are treated with guselkumab according to their usual clinical care will be enrolled. No study drug is provided by the trial instead, the study collects data available from standard care, including ultrasound exam results. Participants will be asked about their health and well-being during the study. The study includes baseline and follow-up assessments up to 52 weeks to monitor disease activity and response to treatment. During the study, participants will undergo musculoskeletal ultrasound evaluations and clinical assessments at various time points, including baseline, week 12, week 24, and week 52. Researchers will track outcomes such as reduction in synovitis scores, disease activity indexes, pain levels, physical function, and treatment persistence. The study also monitors adverse events. Participation involves routine clinical visits and data collection over approximately one year to observe guselkumab treatment effects in real-world use.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the safety and effectiveness of olverembatinib combined with chemotherapy compared to an investigators choice of tyrosine kinase inhibitor TKI combined with chemotherapy in adults newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Ph ALL. This global, randomized, open-label Phase 3 study aims to provide important information about treatment options for this specific type of leukemia. Participants will receive either olverembatinib taken orally every other day along with chemotherapy, or a TKI chosen by the investigator taken orally once daily with chemotherapy. The study includes two groups one receiving the experimental olverembatinib combination and the other receiving the control treatment with investigator-selected TKI. Treatment cycles last 28 days, and the study follows participants through multiple cycles. During the study, participants will be monitored for their response to treatment by checking minimal residual disease negative complete remission rates during the first three cycles. Researchers will also assess event-free survival for up to 3 to 6 years, treatment-related side effects, drug levels in the blood, and quality of life related to leukemia. Safety assessments and other evaluations will continue through approximately two years of study participation, allowing for long-term monitoring of treatment effects and participant health.