Alhambra

Researchers are evaluating the safety and effectiveness of combining ruxolitinib, steroids, and lenalidomide in patients with relapsed or refractory multiple myeloma (MM) who show disease progression. Multiple myeloma is a cancer of plasma cells in the bone marrow, and despite advances in treatment, it remains incurable. This phase 1, open-label, multicenter study aims to explore new therapeutic options by targeting the JAK/STAT pathway involved in MM cell growth and survival. Participants will receive oral ruxolitinib daily on days 1 through 28, lenalidomide on days 1 through 21, and methylprednisolone daily on days 1 through 28 of each treatment cycle. The combination therapy is being studied to determine the maximum tolerated dose of ruxolitinib when used with steroids and lenalidomide. The study also monitors treatment-emergent adverse events over a period of up to 54 months. Throughout the study, participants will undergo various assessments including laboratory tests to monitor blood counts, liver and kidney function, and disease markers. Researchers will evaluate safety, tolerability, and efficacy by tracking adverse events and disease progression. Participants must be able to follow the study schedule and provide informed consent. The study also involves registration in the REVLIMID REMS program for safety monitoring related to lenalidomide use.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating whether fisetin, a natural substance found in strawberries and other foods, can improve physical function in postmenopausal women who have undergone chemotherapy for stage I to III breast cancer. Fisetin may help by removing aged cells that stop dividing but do not die, which build up after chemotherapy and may cause inflammation and damage to healthy cells. This phase II trial aims to test the effect of fisetin on physical function and other health measures in these breast cancer survivors. Participants are randomly assigned to receive either fisetin or a placebo orally on days 1, 2, and 3, with treatment repeating every two weeks for up to eight weeks unless there is disease progression or unacceptable side effects. Blood samples are collected throughout the trial to study biological effects. After treatment, participants are followed yearly for up to three years to monitor long-term outcomes. During the study, participants undergo assessments of physical function including a 6-minute walk test, grip strength, and frailty measures, as well as evaluations of fatigue, neuropathy, cognitive function, quality of life, sleep, anxiety, and depression through questionnaires. Safety and tolerability are monitored using standard criteria, and medication adherence is recorded using a pill diary. The study also explores molecular markers related to aging and inflammation to understand fisetin's biological effects.

This research aims to evaluate whether using GPS tracking can improve medication adherence for hepatitis C treatment among people diagnosed with hepatitis C infection who are also experiencing unsheltered homelessness and receiving street medicine care. The study addresses challenges faced by this population in accessing and continuing hepatitis C treatment within traditional healthcare settings. It will compare adherence rates between patients receiving standard care and those receiving standard care plus GPS tracking support. Participants will be randomly assigned to one of two groups: one will receive usual medical care for hepatitis C, and the other will receive the same care along with a GPS tracker device to assist providers in locating and following up with patients in their environments. Treatment for hepatitis C involves daily medication for 8 to 12 weeks, and the GPS device is intended to support adherence by helping healthcare providers maintain contact with patients in the field. During the study, participants will be monitored for medication adherence and length of their treatment course over 8 to 12 weeks. Researchers will also conduct individual interviews to gather patient perspectives on the use of GPS tracking. The study involves collaboration across multiple sites, focusing on people experiencing unsheltered homelessness who are engaged with street medicine programs. Initial hepatitis C screening occurs outside the study as part of usual care.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating how fisetin, a natural compound found in strawberries, combined with exercise, may help prevent frailty in postmenopausal breast cancer survivors who have completed chemotherapy. This phase II trial focuses on physical function, fatigue, neuropathy, cognitive function, quality of life, and cancer survival outcomes. The study also assesses safety, adherence, and biological markers related to aging cells and inflammation. Participants are randomly assigned to one of four groups: fisetin with exercise, fisetin with a physical activity handout, placebo with exercise, or placebo with a handout. Fisetin or placebo is taken orally on days 1-3 every 14 days for 8 cycles. Exercise training involves 30-45 minutes of aerobic and 20-30 minutes of resistance exercises three times a week for 16 weeks. Blood samples are collected during the study. Throughout the study, participants undergo physical performance tests, questionnaires, and quality-of-life assessments. Wearable devices track heart rate and step count. Follow-up visits occur on days 120 and 180 after treatment, then annually for up to 3 years. The main outcome measured is change in the 6-minute walk distance from baseline to day 120, alongside other physical and health-related outcomes.

Researchers are evaluating whether combining the investigational drug mevrometostat (PF-06821497) with enzalutamide works better than enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study involves participants who have only received limited prior androgen-deprivation therapy and no evidence of disease progression before starting the study. Participants will be randomly assigned to one of two groups: one group receives oral mevrometostat together with oral enzalutamide continuously, while the other group receives a placebo with oral enzalutamide continuously. The study includes a Screening Phase, a Treatment Phase after randomization, followed by Safety Follow-up and Long-Term Follow-up periods to monitor outcomes and side effects. Throughout the study, participants will undergo regular assessments including imaging scans to evaluate disease progression, laboratory tests, and monitoring of symptoms and adverse events. The main outcome measured is Radiographic Progression Free Survival (rPFS) over approximately 4 years from randomization. Safety and long-term effects will also be monitored to understand how well participants tolerate the treatments and how the disease responds over time.