York

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

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 investigating targeted therapies approved by the Food and Drug Administration FDA for patients with advanced cancers that have specific genetic changes. This study, called the Targeted Agent and Profiling Utilization Registry TAPUR Study, aims to understand how safely and effectively these targeted drugs work when prescribed in real-world settings for cancers with actionable genomic variants. The study also collects data on molecular testing choices and helps generate ideas for future clinical trials. Participants receive one of several FDA-approved targeted anticancer drugs, chosen based on specific genetic features of their tumors. These drugs include palbociclib, sunitinib, temsirolimus, trastuzumab with pertuzumab, vemurafenib with cobimetinib, regorafenib, olaparib, nivolumab with ipilimumab, abemaciclib, talazoparib, atezolizumab with talazoparib, tucatinib with trastuzumab, futibatinib, dabrafenib with trametinib, and fam-trastuzumab deruxtecan-nxki. Each treatment follows the approved dosing schedule and duration. Different genetic alterations qualify patients for different drugs, and the study covers a wide range of tumor types, including advanced solid tumors, multiple myeloma, and non-Hodgkin lymphoma. During the study, participants undergo regular assessments including physical exams and imaging tests to measure tumor response using standard criteria. The main outcome measured is the percentage of patients with tumor shrinkage or stable disease after 16 weeks of treatment. Researchers also monitor overall survival for up to three years. Safety and organ function are closely tracked through laboratory tests. Participants must provide informed consent and meet specific eligibility criteria, including measurable disease and acceptable organ function. The study does not use random assignment, and results are shared publicly as they become available and at study completion.