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)

Launched by TANTA UNIVERSITY · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called fenofibrate can help prevent or reduce nerve damage (called peripheral neuropathy) that sometimes happens in people with multiple myeloma who are treated with a common combination of cancer drugs known as VRd (bortezomib, lenalidomide, and dexamethasone). Peripheral neuropathy can cause symptoms like numbness, tingling, or pain in the hands and feet. The study will compare two groups of patients: one group will receive the standard VRd treatment, while the other group will receive VRd plus fenofibrate to see if adding fenofibrate helps protect the nerves.

People who might join this study are adults newly diagnosed with multiple myeloma who are about to start VRd treatment and have good overall health and organ function. Participants will be closely monitored for signs of nerve damage using questionnaires and blood tests throughout their treatment cycles. The study will last for about six treatment cycles, each lasting 28 days. It’s important to note that people who have preexisting nerve problems, certain other health issues, or who are taking specific medications won’t be eligible to join. This trial is not yet recruiting, but it offers a chance to better understand how to protect nerves during multiple myeloma treatment.

Gender

ALL

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.