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RECRUITING

NCT07025005

PHASE4

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)

Sponsor: Tanta University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-30

Completion Date

2026-09-30

Last Updated

2025-11-04

Healthy Volunteers

Conditions

Peripheral Neuropathy Multiple Myeloma, Neoplasms

Interventions

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

Inclusion Criteria: * Age ≥ 18 years old. * Newly diagnosed MM patients according to the revised International Myeloma Working Group Diagnostic Criteria for the diagnosis of Multiple Myeloma (IMWG). * Patients being treated by bortezomib-based VRd chemotherapy regimen. * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate liver function (serum bilirubin \< 1.2 mg/dl) and adequate renal function (serum creatinine \< 1.5 mg/d). Exclusion Criteria: * Patients with prior exposure to neurotoxic agents (Cis-platin, vincristine, taxanes, foscarnet, INH, etc..) in the last 6 months. * Concomitant use of antioxidant vitamins (vitamin A, C, E), anticonvulsants, tricyclic antidepressants, other medications used for neuropathic pain (gabapentin, lamotrigine, carbamazepine). * Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C. * Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis). * Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity). * Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..). * Patients with myopathy. * Patients with other malignancies. * Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis. * Patients with Gallbladder disease and gallstones. * Pregnant and breast-feeding women. * Patients with Known allergy to the fenofibrates. * Concurrent use of statin, colchicine, Ciprofibrate, idelalisib, enzyme inducers (phenytoin, phenobarbitone, carbamazepine,…), enzyme inhibitors (ketoconazole, clarithromycin,…), drugs with high plasma protein binding capacity (Sulfonamides, valproate, oral hypoglycemic, warfarin,…) to avoid potential pharmacodynamics and pharmacokinetic drug interactions.

Locations (2)

Damanhur Oncology Center

Damanhur, El- Behira, Egypt

Tanta University

Tanta, El-Gharbya, Egypt