RecruitingPhase 4NCT07025005

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)

Clinical Study to Evaluate the Possible Role of Fenofibrate in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone Protocol in the Treatment of Patients With Multiple Myeloma

Sponsor

Tanta University

Enrollment

44 participants

Start Date

Aug 30, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Neuropathy Multiple Myeloma, Neoplasms

Summary

This study aims at evaluating the possible beneficial role of Fenofibrate in attenuating the peripheral neuropathy associated with bortezomib (velcade), lenalidomide (revlimid), and dexamethasone (VRd) regimen in newly diagnosed multiple myeloma patients.The study aims to asses VRd protocol induced peripheral neuropathy through: 1. The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) and The use of Neurotoxicity-12 items questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12 for grading of neuropathy at baseline and by the end of every two VRd cycles. 2. The assessment of biological markers: Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL). through comparing two groups: Group one: (Control group; n=22): which will receive 6 cycles of VRd regimen (each cycle will be given every 28 days). Group two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a cholesterol-lowering drug called fenofibrate can prevent nerve damage (peripheral neuropathy) — a common and painful side effect — in newly diagnosed multiple myeloma patients receiving a standard chemotherapy combination called VRd (bortezomib, lenalidomide, and dexamethasone). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with multiple myeloma - Your doctor has prescribed the VRd chemotherapy regimen - You are in reasonably good health (ECOG below 2) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have been exposed to other nerve-damaging drugs (like cisplatin, vincristine, or taxanes) in the past 6 months - You take antioxidant vitamins, anticonvulsants, or certain pain medications for nerve conditions - You already have nerve damage from diabetes, thyroid disease, autoimmune disease, or hepatitis C - You have certain inflammatory bowel conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet

Bortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22. Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22. Fenofibrate 160 mg tablets orally once daily during the period of the 6 cycles of the(VRd) regimen.

DRUGBortezomib + Lenalidomide + Dexamethasone