[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594865":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":66,"collaborators":25,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":25,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fenofibrate group","ACTIVE_COMPARATOR","22 participants will receive 6 cycles of (VRd) regimen plus Fenofibrate 160 mg tablet once daily during the period of the 6 cycles.",[13],"Drug: Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","22 participants will receive 6 cycles of VRd regimen (each cycle will be given for 28 days)",[18],"Drug: Bortezomib + Lenalidomide + Dexamethasone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bortezomib + Lenalidomide + Dexamethasone + Fenofibrate 160 mg tablet","Bortezomib (VELCADE® 3.5mg\u002Fml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg\u002FmL then the dose will be 1.3 mg\u002Fm2 administered subcutaneously at thigh or abdomen at days 1,8,15,22.\n\nLenalidomide 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.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Bortezomib + Lenalidomide + Dexamethasone","Bortezomib (VELCADE® 3.5mg\u002Fml) is diluted by 1.4 ml of normal saline (0.9%) solution to give a solution of a concentration of 2.5 mg\u002FmL then the dose will be 1.3 mg\u002Fm2 administered subcutaneously at thigh or abdomen at days 1,8,15,22.\n\nLenalidomide is given as 25mg orally at days from 1 to 21. Dexamethasone is given as 40mg orally at days 1,8,15,22.",[15],[31],{"name":32,"affiliation":33,"role":34},"Ashraf M Alaa, BSc of clinical pharmacy","clinical pharmacy departement - Faculty of Pharmacy - Tanta University","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+201011301390","ashraf.alaa@pharm.tanta.edu.eg",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Sahar M El-Haggar, Professor of Clinical Pharmacy","+201008838807","sahr.elhaggar@pharm.tanta.edu.eg",[45,58],{"facility":46,"status":47,"city":48,"state":49,"zip":25,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":25},"Damanhur Oncology Center","RECRUITING","Damanhur","El- Behira","Egypt","EG",{"type":53,"coordinates":54},"Point",[55,56],30.46823,31.03408,{"lat":56,"lon":55},{"facility":5,"status":47,"city":59,"state":60,"zip":25,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"Tanta","El-Gharbya",{"type":53,"coordinates":62},[63,64],31.00192,30.78847,{"lat":64,"lon":63},{"type":34,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ashraf Mohamed Alaa Mokhtar","Instructor at Clinical Pharmacy Department -Faculty of Pharmacy- Tanta University","100594865","phase-4-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-100594865",false,"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)","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","VRd MM Fibrate","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Newly diagnosed MM patients according to the revised International Myeloma Working Group Diagnostic Criteria for the diagnosis of Multiple Myeloma (IMWG).\n* Patients being treated by bortezomib-based VRd chemotherapy regimen.\n* Patients with performance status \\\u003C2 according to Eastern Cooperative Oncology Group (ECOG) score.\n* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL and hemoglobin level ≥ 10 g\u002Fdl).\n* Patients with adequate liver function (serum bilirubin \\\u003C 1.2 mg\u002Fdl) and adequate renal function (serum creatinine \\\u003C 1.5 mg\u002Fd).\n\nExclusion Criteria:\n\n* Patients with prior exposure to neurotoxic agents (Cis-platin, vincristine, taxanes, foscarnet, INH, etc..) in the last 6 months.\n* Concomitant use of antioxidant vitamins (vitamin A, C, E), anticonvulsants, tricyclic antidepressants, other medications used for neuropathic pain (gabapentin, lamotrigine, carbamazepine).\n* Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.\n* Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).\n* Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity).\n* Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..).\n* Patients with myopathy.\n* Patients with other malignancies.\n* Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis.\n* Patients with Gallbladder disease and gallstones.\n* Pregnant and breast-feeding women.\n* Patients with Known allergy to the fenofibrates.\n* 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.","ALL","18 Years",{"count":80,"type":81},44,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","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:\n\n1. 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\u002FGynecologic Oncology Group \"FACT\u002FGOG-Ntx-12 for grading of neuropathy at baseline and by the end of every two VRd cycles.\n2. The assessment of biological markers:\n\nBrain -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).\n\nGroup two: (Fenofibrate group; n=22): which will receive the same regimen plus Fenofibrate 160 mg once daily.",[87,88],"Peripheral Neuropathy","Multiple Myeloma, Neoplasms",[90,91,92,93,94,95],"peripheral neuropathy","multiple myeloma","bortezomib induced peripheral neuropathy (BIPN)","Fenofibrate","VRd protocol","lenalidomide","2025-11-01",{"date":98,"type":99},"2025-11-04","ACTUAL",{"date":101,"type":99},"2025-08-30",{"date":103,"type":81},"2026-09-30",{"name":5,"class":6},2]