Damanhour

Researchers are evaluating the possible protective role of fenofibrate in reducing peripheral neuropathy caused by the combination of bortezomib, lenalidomide, and dexamethasone (VRd) in patients newly diagnosed with multiple myeloma. This trial aims to assess VRd-induced peripheral neuropathy using both clinical grading scales—the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) and the Neurotoxicity-12 item questionnaire (Ntx-12)—at baseline and after every two cycles of VRd therapy over six cycles. The study also measures biological markers such as brain-derived neurotrophic factor (BDNF) and neurofilament light chain (NfL) to understand neuropathy development better. Participants are divided into two groups: a control group receiving six cycles of the standard VRd regimen (bortezomib, lenalidomide, and dexamethasone) with each 28-day cycle, and an intervention group receiving the same VRd regimen plus fenofibrate 160 mg orally once daily throughout the six cycles. Bortezomib is administered subcutaneously on days 1, 8, 15, and 22 of each cycle, lenalidomide is given orally at 25 mg daily from days 1 to 21, and dexamethasone is taken orally at 40 mg on days 1, 8, 15, and 22. Participants will be closely monitored with neuropathy assessments using the NCI-CTCAE and Ntx-12 questionnaires at baseline and after every two cycles of treatment. Researchers will evaluate changes in neuropathy grades and questionnaire scores, alongside blood tests measuring BDNF and NfL levels. The study focuses on peripheral neuropathy development during the 6-cycle VRd treatment period, with a total participation duration covering these treatment cycles and related assessments.