NCT07025005

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multiple myeloma is considered an incurable disease so several regimens are available for the management of multiple myeloma. Among these regimens there is the bortezomib, lenalidomide and dexamethasone (RVd or VRd) regimen which is the preferred induction regimen for most patients with newly diagnosed multiple myeloma (NDMM). Bortezomib has hematologic and non-hematologic adverse reactions. From the non-hematologic adverse reactions there is the bortezomib-induced peripheral neuropathy (BIPN) that remains the most intractable common adverse reactions that occur during bortezomib treatment with no recommended therapies available for preventing or treating existing BIPN. Fenofibrate a peroxisome proliferator-activated receptor-alpha (PPARα) agonist that is widely used in the management of hypercholesterolemia and hypertriglyceridemia has been proposed as a key lipid metabolism modulator and regulator of inflammation. Preclinical studies showed that treatment with fenofibrate partially reversed and prevented the development of mechanical and cold hypersensitivity induced by paclitaxel through the regulation of peroxisome proliferator-activated receptor-alpha (PPAR-α) expression and decrease neuroinflammation in the dorsal root ganglia (DRG) without decreasing the antitumoral effect of paclitaxel.

Conditions

• Peripheral Neuropathy
• Multiple Myeloma, Neoplasms

Interventions

Type	Name	Description
DRUG	Bortezomib + 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.
DRUG	Bortezomib + Lenalidomide + Dexamethasone	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.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-06-17
• Last updated: 2025-11-04

Locations

2 sites across 1 country: Egypt

Regulatory

• FDA-regulated drug study