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)
| NCT ID | NCT07025005 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tanta University |
| Condition | Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-08-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 44 participants in total. It began in 2025-08-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ashraf M Alaa, BSc of clinical pharmacy
PRINCIPAL INVESTIGATOR
clinical pharmacy departement - Faculty of Pharmacy - Tanta University
Frequently Asked Questions
Who can join the NCT07025005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07025005 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07025005 currently recruiting?
Yes, NCT07025005 is actively recruiting participants. Contact the research team at ashraf.alaa@pharm.tanta.edu.eg for enrollment information.
Where is the NCT07025005 trial being conducted?
This trial is being conducted at Damanhur, Egypt, Tanta, Egypt.
Who is sponsoring the NCT07025005 clinical trial?
NCT07025005 is sponsored by Tanta University. The principal investigator is Ashraf M Alaa, BSc of clinical pharmacy at clinical pharmacy departement - Faculty of Pharmacy - Tanta University. The trial plans to enroll 44 participants.