Study of Fenofibrate to Prevent Peripheral Neuropathy in Multiple Myeloma Patients Treated with Bortezomib, Lenalidomide, and Dexamethasone VRd

What this Trial Is About

Researchers are evaluating the possible role of Fenofibrate in reducing peripheral neuropathy caused by the VRd regimen, which includes bortezomib, lenalidomide, and dexamethasone, in patients newly diagnosed with multiple myeloma. This study focuses on assessing neuropathy using standardized grading scales and questionnaires, along with biological markers such as Brain-derived neurotrophic factor BDNF and Neuro-filament light chain NfL. The trial compares two groups of patients receiving VRd treatment, one with Fenofibrate added and one without. Participants are randomly assigned to one of two groups the Fenofibrate group receives 6 cycles of the VRd regimen plus Fenofibrate 160 mg orally once daily during the treatment cycles the control group receives only the 6 cycles of the VRd regimen every 28 days. Bortezomib is given subcutaneously at specific days in each cycle, lenalidomide is taken orally for 21 days, and dexamethasone is administered orally on four days per cycle. The study interventions last through the 6 cycles of VRd treatment. During the trial, neuropathy severity is evaluated at baseline and after every two VRd cycles using the NCI-CTCAE criteria and a neurotoxicity questionnaire. Blood samples are collected to measure BDNF and NfL levels at the start and within one week after the final VRd cycle. Researchers monitor changes in neuropathy grades, questionnaire scores, and biological markers to understand the impact of Fenofibrate. Participants are followed throughout the treatment period, which lasts approximately six months.

Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone (VRd) Protocol in the Treatment of Patients With Multiple Myeloma (MM)