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)
NCT ID: NCT07025005
Last Updated: 2025-11-04
Study Results
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Basic Information
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RECRUITING
PHASE4
44 participants
INTERVENTIONAL
2025-08-30
2026-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
SINGLE
Study Groups
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Fenofibrate group
22 participants will receive 6 cycles of (VRd) regimen plus Fenofibrate 160 mg tablet once daily during the period of the 6 cycles.
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.
Control group
22 participants will receive 6 cycles of VRd regimen (each cycle will be given for 28 days)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ashraf Mohamed Alaa Mokhtar
Instructor at Clinical Pharmacy Department -Faculty of Pharmacy- Tanta University
Principal Investigators
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Ashraf M Alaa, BSc of clinical pharmacy
Role: PRINCIPAL_INVESTIGATOR
clinical pharmacy departement - Faculty of Pharmacy - Tanta University
Locations
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Damanhur Oncology Center
Damanhur, El- Behira, Egypt
Tanta University
Tanta, El-Gharbya, Egypt
Countries
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Central Contacts
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References
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Jin L, Hua H, Ji Y, Jia Z, Peng M, Huang S. Anti-inflammatory role of fenofibrate in treating diseases. Biomol Biomed. 2023 May 1;23(3):376-391. doi: 10.17305/bb.2022.8534.
Azoulay D, Lavie D, Horowitz N, Suriu C, Gatt ME, Akria L, Perlman R, Braester A, Ben-Yehuda D. Bortezomib-induced peripheral neuropathy is related to altered levels of brain-derived neurotrophic factor in the peripheral blood of patients with multiple myeloma. Br J Haematol. 2014 Feb;164(3):454-6. doi: 10.1111/bjh.12624. Epub 2013 Oct 25. No abstract available.
Cebulla N, Schirmer D, Runau E, Flamm L, Gommersbach S, Stengel H, Zhou X, Einsele H, Reinhold AK, Rogalla von Bieberstein B, Zeller D, Rittner H, Kortum KM, Sommer C. Neurofilament light chain levels indicate acute axonal damage under bortezomib treatment. J Neurol. 2023 Jun;270(6):2997-3007. doi: 10.1007/s00415-023-11624-2. Epub 2023 Feb 18.
Caillaud M, Patel NH, White A, Wood M, Contreras KM, Toma W, Alkhlaif Y, Roberts JL, Tran TH, Jackson AB, Poklis J, Gewirtz DA, Damaj MI. Targeting Peroxisome Proliferator-Activated Receptor-alpha (PPAR- alpha) to reduce paclitaxel-induced peripheral neuropathy. Brain Behav Immun. 2021 Mar;93:172-185. doi: 10.1016/j.bbi.2021.01.004. Epub 2021 Jan 9.
Esmaeili MA, Yadav S, Gupta RK, Waggoner GR, Deloach A, Calingasan NY, Beal MF, Kiaei M. Preferential PPAR-alpha activation reduces neuroinflammation, and blocks neurodegeneration in vivo. Hum Mol Genet. 2016 Jan 15;25(2):317-27. doi: 10.1093/hmg/ddv477. Epub 2015 Nov 24.
Yamamoto S, Egashira N. Pathological Mechanisms of Bortezomib-Induced Peripheral Neuropathy. Int J Mol Sci. 2021 Jan 17;22(2):888. doi: 10.3390/ijms22020888.
Other Identifiers
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36264MS945/5/25
Identifier Type: -
Identifier Source: org_study_id
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