Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lena
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 neuropath
| Condition(s) | Peripheral Neuropathy, Multiple Myeloma, Neoplasms |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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-fila |
| Who can participate | 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. * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tanta University |
| Locations | Damanhur, El- Behira, Egypt; Tanta, El-Gharbya, Egypt |
| Start date | 2025-08-30 |
| NCT ID | NCT07025005 |
| Official listing | https://clinicaltrials.gov/study/NCT07025005 |