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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Age: 18Years +All GendersPhase 3
707 locations
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Actively Recruiting

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.

Age: 18Years +All Genders
2284 locations
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Actively Recruiting

Researchers are evaluating the use of FDA-approved targeted therapies in patients aged 12 years and older with advanced cancer, including solid tumors, multiple myeloma, and non-Hodgkin lymphoma. The study aims to understand the safety and effectiveness of these drugs when prescribed based on specific genetic changes found in tumors. This Phase 2 trial collects real-world data from patients whose cancer has not responded to standard treatments or for whom no standard treatment is available. Participants receive one or more targeted drugs selected according to their tumor's genetic profile. Some of the drugs studied include Palbociclib, Sunitinib, Temsirolimus, Trastuzumab and Pertuzumab, Vemurafenib and Cobimetinib, Regorafenib, Olaparib, and others. Treatment plans vary based on the specific drug and tumor genetics. The study does not include all possible targeted therapies in its published details, but additional information is available through the study contacts. During the study, participants are monitored regularly to assess their cancer's response to treatment, measured by complete or partial tumor shrinkage or disease stabilization at 16 weeks. Assessments include physical and radiographic exams and genomic testing. Safety and organ function are also monitored. The study collects ongoing data from participants, including their treatment outcomes and any side effects, with results shared publicly as they become available. The trial continues to enroll patients and follow their progress over time.

Age: 12Years +All GendersPhase 2
174 locations