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OncoMatch/Clinical Trials/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)

Is NCT07025005 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet and Bortezomib + Lenalidomide + Dexamethasone for peripheral neuropathy.

Phase 4RecruitingTanta UniversityNCT07025005Data as of May 2026

Treatment: Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet · Bortezomib + Lenalidomide + DexamethasoneThis 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: neurotoxic agent (cis-platin, vincristine, taxanes, foscarnet, isoniazid)

prior exposure to neurotoxic agents (Cis-platin, vincristine, taxanes, foscarnet, INH, etc..) in the last 6 months

Lab requirements

Blood counts

absolute neutrophilic count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin level ≥ 10 g/dl

Kidney function

serum creatinine < 1.5 mg/dl

Liver function

serum bilirubin < 1.2 mg/dl

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).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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