Monterey

Researchers are evaluating a combination therapy of ruxolitinib, steroids, and lenalidomide in adults with relapsed or refractory multiple myeloma MM who have progressive disease despite previous treatments. MM is a cancer of plasma cells in the bone marrow with complex causes and limited curative options. This phase 1, open-label, multicenter study aims to assess the safety and effectiveness of these drugs together in patients who have failed at least two prior therapies including immunomodulatory drugs and proteasome inhibitors. Participants receive varying doses of ruxolitinib orally twice daily, lenalidomide once daily, and methylprednisolone every other day. The study includes dose escalation periods and treatment adjustments based on disease progression. Some groups start with ruxolitinib and steroids, adding lenalidomide only if the disease worsens. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will have regular evaluations including blood tests and clinical assessments to monitor safety, side effects, and treatment response. Researchers will measure outcomes such as the maximum tolerated dose, adverse events, response rates, progression-free and overall survival over a follow-up period extending up to 54 months. Participants are expected to adhere to visit schedules and study requirements throughout the trial.

Researchers are conducting an observational registry to collect standardized data from adult patients receiving routine oncology care at participating cancer centers. The study aims to gather detailed information such as baseline patient characteristics, treatments administered, and outcomes to support research and improve clinical trial participation. Patient surveys are also included to enrich the data collected. No treatments or interventions are given as part of this registry. Instead, data is gathered from patients receiving their usual cancer care. This open-ended registry will continuously collect and analyze information over time to better understand treatment patterns, safety, and effectiveness. Participants will provide informed consent and contribute data through their regular care visits and surveys. Researchers will monitor treatment effectiveness mainly by tracking the time until treatment discontinuation. The registry will regularly analyze and present the data collected. Participation may last as long as the patient is receiving treatment and contributing data, with long-term follow-up possible.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are conducting an observational study to create precision external control groups using current and future data from patients with advanced or metastatic non-small cell lung cancer NSCLC. This study aims to evaluate different patient cohorts based on specific genetic mutations, PD-L1 status, and lines of therapy to better understand outcomes in this population. Participants are grouped into various cohorts depending on their treatment stage and genetic profile, including those starting first line therapy with immune checkpoint inhibitors ICI, patients with actionable EGFR or KRAS mutations, and those receiving second or later line therapies. The study collects information on patients receiving treatments such as ICI alone or in combination with chemotherapy, targeted therapies like osimertinib, and other physician-chosen regimens. During the study, participants medical data and treatment responses will be observed without intervention. Researchers will assess objective response rates, progression-free survival, overall survival, and time to next treatment across cohorts from September 2025 to April 2029. Participants will be followed over time to gather this information, with no additional treatments or procedures mandated by the study.

Researchers are comparing two approaches to supportive cancer care for adults with cancer. This trial aims to evaluate which method better improves health-related quality of life, patient activation, satisfaction with care and decision-making, documentation of goals and symptoms, and reduces acute care use such as emergency visits and hospitalizations. The study focuses on patients with newly diagnosed or recurrent solid tumor cancers. Participants are assigned to one of two groups. One group receives educational materials about advance care planning and symptom management through technology messages weekly for the first 4 months and biweekly for months 5 through 12. The other group works with a lay health worker who discusses the same materials in person or by phone on the same schedule over 12 months. Both groups receive ongoing supportive care tailored to improve their cancer experience. Participants complete a baseline interview at enrollment by phone, followed by surveys at 3, 6, and 12 months. Researchers track changes in quality of life using the FACT-G questionnaire, patient activation, satisfaction with care and decision-making, use of palliative and hospice care, emergency visits, hospitalizations, and documentation of care goals and symptoms. The study runs through February 2028, allowing long-term monitoring of supportive care outcomes.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating how tailored telehealth psychotherapy environments affect clinical outcomes for children with mood and anxiety disorders. This Phase II randomized trial compares Teleo, a virtual therapy platform designed specifically for youth psychotherapy, to standard video conferencing platforms like Zoom. The study will assess patient engagement and various clinical metrics including treatment duration, medication needs, and symptoms of anxiety and depression. Participants will be randomly assigned to receive 12 sessions of therapist-led psychotherapy either through the Teleo platform or standard video conferencing methods. Sessions will be recorded, and clinical data along with questionnaires will be collected. The trial will monitor cancellation and no-show rates, clinician satisfaction, and treatment dropout over a 12-week period. Families involved in the study will complete assessments such as the Child Involvement Rating Scale during the first week and repeated measures of anxiety, depression, and therapy perceptions at multiple points. Researchers will also track long-term care costs one year after enrollment. Participation includes regular therapy sessions and questionnaire completion, with ongoing evaluation of both clinical and engagement outcomes until the study ends in 2027.

Researchers are building a prospective group of patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have specific common EGFR mutations. This observational study collects standardized data at the start, during treatment, and when treatment ends. About 30% of patients who join before starting osimertinib treatment will have imaging done at regular intervals. Participants receive either osimertinib combined with chemotherapy or other treatments started after January 1, 2024, or receive osimertinib alone as the first treatment for metastatic NSCLC. The study tracks real-world outcomes such as how long patients live without the disease worsening, overall survival, and how long patients stay on treatment. During the study, patients will have their health and treatment progress monitored through data collection and imaging when applicable. Researchers will measure progression-free survival up to 100 months from starting first-line treatment, along with overall survival and time until treatment stops. The study is expected to continue until April 2029.