Chivilcoy

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 evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.