Fenofibrate to prevent nerve damage from VRd (bortezomib/lenalidomide/dexamethasone) in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 4 study compares standard VRd induction chemotherapy alone to VRd plus fenofibrate 160 mg in adults with newly diagnosed multiple myeloma. Participants receive six 28-day cycles of bortezomib, lenalidomide, and dexamethasone, with the fenofibrate group taking daily 160 mg tablets. Neuropathy is monitored every two cycles using NCI-CTCAE v5 and the FACT/GOG-Ntx-12 questionnaire, and blood biomarkers BDNF and neurofilament light chain (NfL) are measured. Outcomes will compare neuropathy scores and biomarker changes between groups to see if fenofibrate reduces the frequency or severity of bortezomib-induced peripheral neuropathy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Damanhur Oncology Center
  Damanhur, El- Behira, Egypt Recruiting
• Tanta University
  Tanta, El-Gharbya, Egypt Recruiting

Study contacts

• Principal investigator: Ashraf M Alaa, BSc of clinical pharmacy — clinical pharmacy departement - Faculty of Pharmacy - Tanta University
• Study coordinator: Ashraf M Alaa, BSc of clinical pharmacy
• Email: ashraf.alaa@pharm.tanta.edu.eg
• Phone: +201011301390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.