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.
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.
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).
Parallel
Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet
DrugBortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22. Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22. Fenofibrate 160 mg tablets orally once daily during the period of the 6 cycles of the(VRd) regimen.
Bortezomib + Lenalidomide + Dexamethasone
DrugBortezomib (VELCADE® 3.5mg/ml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg/mL then the dose will be 1.3 mg/m2 administered subcutaneously at thigh or abdomen at days 1,8,15,22. Lenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22.
The change in percentage of patients with peripheral neuropathy grade ≥ 2 with the variation of both 12-item neurotoxicity questionnaire (Ntx-12) total score and NCI-CTCAE, v5.
The change in percentage of patients with peripheral neuropathy grade ≥ 2 using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI-CTCAE, v5) ( where the higher the score the more severity of the peripheral neuropathy) and the use of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 12 Item Version (FACT/GOG-NTX-12) to assess (where the higher the score, the better the Quality of life).
The change in serum levels of the measured biological markers Brain -derived neurotrophic factor (BDNF) and Neuro-filament light chain (NfL).
The assessment of serum level of the biological markers: Brain -derived neurotrophic factor (BDNF) (in ng/ml) and Neuro-filament light chain (NfL)( in pg/ml) will be done at the baseline (before the initiation of the treatment protocol) and within 1 week after the last VRd cycle (the 6th cycle) ( the duration of each cycle is 28 days).
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