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18F-Fludarabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F-Fludarabine","Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Caroline Bodet-Milin, MD","CONTACT","33240084136","caroline.milin@chu-nantes.fr",[28,46,60,73,86,96,101],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CHU d'Angers","RECRUITING","Angers","49100","France","FR",{"type":36,"coordinates":37},"Point",[38,39],-0.55202,47.47156,{"lat":39,"lon":38},[42,44],{"name":43,"role":24,"phone":20,"phoneExt":20,"email":20},"Pacôme Fosse, MD",{"name":43,"role":45,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":47,"status":30,"city":48,"state":20,"zip":49,"country":33,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"CHU de 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Tours","Tours","37000",{"type":36,"coordinates":106},[107,108],0.70398,47.39484,{"lat":108,"lon":107},[111,113],{"name":112,"role":24,"phone":20,"phoneExt":20,"email":20},"Maria Joao Santiago-Ribeiro, MD",{"name":112,"role":45,"phone":20,"phoneExt":20,"email":20},{"type":115,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[117],{"name":118,"class":119},"Cyceron","UNKNOWN","100349616","phase-1-evaluation-of-pet-18f-fludarabine-for-the-initial-assessment-and-end-treatment-of-symptomatic-multiple-myeloma-patients-100349616",false,"NCT03832127","Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients","Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft","Myelofludate","Inclusion Criteria:\n\n* Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation.\n* Patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to ESMO's European recommendations\n* MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).\n* Patient affiliated with a social insurance scheme\n* The patient must understand and voluntarily sign the informed consent form\n* Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.)\n* Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET.\n* Male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last PET.\n* HIV serology known to be negative\n* Karnofsky ≥ 70 or ECOG 0-1\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy or breastfeeding\n* Male or female refusing birth control conditions\n* Primary AL amyloidosis and myeloma complicated by amyloidosis\n* Neutropenia \\\u003C1000 PN \u002F mm3\n* Thrombocytopenia \\\u003C70,000 \u002F mm3\n* Hepatic impairment: bilirubin\\> 35μmol \u002F L and SGOT, SGPT, alkaline phosphatase greater than 3 N\n* Renal impairment defined by creatinine clearance \\\u003C50 ml \u002F min\n* History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer\n* Severe active infection\n* Active infection with known hepatitis B or C virus.\n* Patient with insulin-dependent or non-insulin-dependent diabetes mellitus.\n* Intolerance or known allergy to any of the study drugs or any of its analogues\n* Psychiatric illness that may interfere with participation in the study\n* Patient under safeguard of justice\n* Intellectual inability to sign informed consent\n* Persons protected by law","ALL","18 Years",{"count":131,"type":132},35,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.",[138],"Myeloma","2024-06-12",{"date":141,"type":142},"2024-06-14","ACTUAL",{"date":144,"type":142},"2022-09-09",{"date":146,"type":132},"2026-09-09",{"name":5,"class":6},7]