Actively Recruiting
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)
Led by Tanta University · Updated on 2025-11-04
44
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Newly diagnosed multiple myeloma patients according to the revised International Myeloma Working Group Diagnostic Criteria.
- Receiving bortezomib-based VRd chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
- Adequate baseline blood counts: absolute neutrophil count 1.5 10^9/L, platelet count 100 10^9/L, hemoglobin 10 g/dl.
- Adequate liver function with serum bilirubin less than 1.2 mg/dl.
- Adequate kidney function with serum creatinine less than 1.5 mg/dl.
You will not qualify if you...
- Prior exposure within 6 months to neurotoxic drugs like cisplatin, vincristine, taxanes, foscarnet, or INH.
- Current use of antioxidant vitamins (A, C, E), anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications.
- Existing peripheral neuropathy from other causes such as diabetes, brain disorders, hypothyroidism, autoimmune diseases, or hepatitis C.
- Presence of inflammatory diseases like ulcerative colitis or rheumatoid arthritis.
- Conditions related to oxidative stress including smoking, tuberculosis, or obesity.
- Active liver diseases such as cirrhosis, fatty liver, or hepatitis C.
- Myopathy.
- Other cancers.
- Kidney impairment including end-stage renal disease or dialysis.
- Gallbladder disease or gallstones.
- Pregnancy or breastfeeding.
- Known allergy to fenofibrates.
- Concurrent use of statins, colchicine, ciprofibrate, idelalisib, enzyme inducers or inhibitors, or drugs with high plasma protein binding capacity to avoid drug interactions.
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Trial Site Locations
Total: 2 locations
1
Damanhur Oncology Center
Damanhur, El- Behira, Egypt
Actively Recruiting
2
Tanta University
Tanta, El-Gharbya, Egypt
Actively Recruiting
Research Team
A
Ashraf M Alaa, BSc of clinical pharmacy
CONTACT
S
Sahar M El-Haggar, Professor of Clinical Pharmacy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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