Studies fenofibrate for nerve side effects of myeloma treatment
Tests whether fenofibrate may ease nerve damage in adults with newly diagnosed multiple myeloma.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Damanhur and Tanta, EgyptSee the 2 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed multiple myeloma who are being treated with the VRd regimen (bortezomib, lenalidomide, dexamethasone). It tests whether fenofibrate can help prevent nerve damage caused by this treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed multiple myeloma. Performance status below 2 (ECOG score).
- Earlier treatment
- Must be treated with the bortezomib-based VRd regimen. Cannot have had neurotoxic agents (such as cis-platin, vincristine, taxanes, foscarnet, INH) in the last 6 months.
- Biomarker or test result
- Adequate blood counts: absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 10 g/dl. Serum bilirubin < 1.2 mg/dl and serum creatinine < 1.5 mg/d.
Main reasons for not taking part
- Nerve damage (peripheral neuropathy) from other causes, such as diabetes
- Active liver disease, myopathy, gallbladder disease or gallstones
- Renal impairment, including dialysis
- Other cancers
- Pregnant or breast-feeding women
Read by machine on 12 November 2026.
Where in Egypt
- Damanhur Oncology CenterDamanhur, EgyptContact: Ashraf M Alaa, BSc of clinical pharmacyTaking people
- Tanta universityTanta, EgyptContact: Ashraf M Alaa, BSc of clinical pharmacyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tanta University
- Trial code
- NCT07025005
- Record updated
- 4 November 2025
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: 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); Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis; 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; 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 other malignancies; Patients with Gallbladder disease and gallstones; Patients with Known allergy to the fenofibrates; Patients with myopathy; Pregnant and breast-feeding women.