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Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating an experimental drug called linvoseltamab in adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplantation. The study focuses on comparing the effects and safety of linvoseltamab against the standard treatment in this group of patients. This is a Phase 3 randomized, open-label study involving transplant-ineligible multiple myeloma patients. Participants will receive either linvoseltamab according to the study protocol or a combination of daratumumab, lenalidomide, and dexamethasone as the standard treatment. The trial includes an induction phase with daratumumab, lenalidomide, and dexamethasone followed by treatment with linvoseltamab or continuation of the standard therapy. All drugs are administered as directed by the study protocol. During the study, participants will be closely monitored for disease response and safety over a period of up to 11 years. Researchers will measure outcomes such as minimal residual disease status, progression-free survival based on specific criteria, and treatment response assessed by blinded independent review. Safety and long-term effects will also be evaluated throughout the study duration.

Researchers are studying patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) who are at high risk of cancer recurrence. The study focuses on patients treated with ribociclib or abemaciclib combined with endocrine therapy (ET) in the adjuvant setting. It aims to understand clinical and pathological features, treatment outcomes, and recurrence patterns, especially among those who relapse during or within 12 months after receiving CDK4/6 inhibitors with ET. The study observes patients who have started or are starting adjuvant treatment with CDK4/6 inhibitors (either abemaciclib or ribociclib) plus endocrine therapy since January 1, 2021. There are no experimental treatments assigned, as this is an observational study conducted in multiple centers. It collects real-world data on therapeutic choices and patient responses to these treatments in a routine clinical setting. Participants will have their clinical and pathological data reviewed, including disease characteristics and treatment histories. Researchers will monitor disease-free survival over three years to evaluate invasive-disease free survival (IDFS). The study also examines recurrence patterns and outcomes for patients relapsing during or shortly after adjuvant therapy. Data consent and performance status assessments are part of participant involvement to ensure compliance and safety during the study period.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are investigating patients affected by aneurysmal subarachnoid hemorrhage (aSAH), a type of hemorrhagic stroke caused by the rupture of a brain aneurysm, leading to bleeding in the space around the brain. Although early treatment has improved survival, many patients still develop long-term disabling neurological problems. The study focuses on delayed ischemic neurological deficit (DIND), a condition that can lead to delayed cerebral ischemia (DCI) and worsened neurological outcomes. There is no established standard for diagnosing or treating DIND, and the trial aims to describe its incidence, diagnostic imaging findings, and different treatment approaches across centers. The study observes patients with aSAH who require intensive care admission. Early aneurysm repair within 24 to 72 hours is standard, using techniques like endovascular coiling or surgical clipping. The trial collects data on clinical neurological exams and instrumental monitoring such as EEG and ultrasound to identify DIND. Various treatments for DIND are evaluated, including blood pressure management, intra-arterial vasodilator drugs, and mechanical angioplasty. The study also considers innovative methods like stent retriever angioplasty. No specific interventions are assigned by the study; it compares existing diagnostic and therapeutic strategies used in different centers. Participants undergo neurological assessments, brain imaging, and continuous monitoring to detect DIND and evaluate neurological outcomes over time. Researchers collect data on mortality and functional status in the short and long term, as well as treatment intensity and usefulness. The primary measure is the incidence of DIND within 12 months. The total duration of participation depends on patient follow-up. This comprehensive monitoring helps understand how different approaches impact patient recovery and complications after aSAH.

This is a multicentric prospective observational study in which consecutive patients diagnosed with Psoriatic Arthritis (any subset) and Rheumatoid Arthritis, that according to clinicians' evaluation should be treated with Upadacitinib therapy, will be recruited from the outpatient clinic of the Rheumatology Department of the centers included in the study. The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria, from the outpatient clinic of the Rheumatology Units of the participating centers. Written informed consent will be obtained prior to the beginning of the study. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory, and imaging assessment in order to define the disease activity according to standardized disease activity indexes, at baseline and during the first 3 follow-up visits. For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis, the follow-up visits are generally scheduled after 1 month (± 1 week), 3 months (± 2 weeks), and 6 months (± 4 weeks) post-treatment initiation, in accordance with international guidelines and local protocols. In case of suspicion of axial involvement, an MRI of the sacroiliac joints will be performed at baseline and, in case of positivity, will be repeated after 6 months (±1 month) in order to assess disease activity at the spine and the treatment efficacy. Regarding the Patient Reported Outcome, the investigators will assess these during the scheduled visits, and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement. The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit, and subsequently participants will return these during the first follow-up visit. The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form.

Researchers are investigating the use of elacestrant compared to standard endocrine therapy in patients with estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have a relapse detected by circulating tumor DNA (ctDNA). This international, multi-center, randomized, open-label phase III trial aims to determine if elacestrant offers a benefit over current endocrine treatments in this group of patients without distant metastases. The study includes a lengthy ctDNA screening phase to identify eligible participants and monitor their disease status over time. The study begins with a ctDNA screening phase, where patients receive standard adjuvant endocrine therapy such as tamoxifen, letrozole, anastrozole, or exemestane, and have blood collected every six months for ctDNA testing until about 5.7 years after enrollment ends. Those who test positive for ctDNA and show no distant metastasis on imaging will be randomized within four weeks to continue their current endocrine therapy or switch to elacestrant taken orally at 400 mg daily. Treatment duration varies based on prior endocrine therapy exposure, ranging from two to seven years. After treatment, further care is at the physician's discretion. Participants will have frequent follow-up visits with ctDNA testing at weeks 4 and 16 post-randomization and every 16 weeks thereafter for up to three years. Imaging studies including mammograms, bone scans, and CT scans will be conducted regularly to monitor for distant metastases or new cancers. The main outcome measured is distant metastasis-free survival, assessed up to 6.25 years following the first patient enrollment. The study ends when all patients complete their visits or discontinue for reasons such as withdrawal, loss to follow-up, or death, and data is fully analyzed and finalized.

Researchers are studying patients with stage IV synchronous oligometastatic non-small cell lung cancer (NSCLC) who have not progressed after initial treatment with cemiplimab, with or without platinum-based chemotherapy and radical treatment. This phase II, multi-center, double-blind, placebo-controlled study aims to find out if continuing cemiplimab treatment for up to 12 months improves progression-free survival compared to placebo. Eligible patients have a limited number of metastases and meet specific health criteria to participate. Participants are randomly assigned in equal numbers to receive either cemiplimab or a placebo. Cemiplimab is supplied in 10 ml glass vials, while the placebo is a standard saline solution. After randomization, patients continue their assigned treatment during the consolidation phase, which lasts up to 12 months. Throughout the study, patients undergo regular disease assessments including imaging and blood tests to monitor their condition. During the study, participants will attend follow-up visits for evaluations of their health status and disease progression. Researchers will measure progression-free survival over a period of nine years from the first patient randomized. Safety and treatment effects are closely monitored through these assessments. The trial includes detailed eligibility checks before registration and again before randomization to ensure patients meet all requirements.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.