Title
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
Phase
Phase 1Lead Sponsor
University of NantesStudy Type
InterventionalStatus
Not yet recruitingIndication/Condition
MyelomaIntervention/Treatment
18F-FludarabineStudy Participants
35The 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.
Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma
Inclusion Criteria: Symptomatic MM in the first line in patients who are not candidates for autologous bone marrow transplantation. 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 MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary). Patient affiliated with a social insurance scheme The patient must understand and voluntarily sign the informed consent form Women of childbearing potential must have a serum pregnancy test (performed within 2 days before each PET scan.) Women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last PET. 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. HIV serology known to be negative Karnofsky ≥ 70 or ECOG 0-1 Exclusion Criteria: Age under 18 years Pregnancy or breastfeeding Male or female refusing birth control conditions Primary AL amyloidosis and myeloma complicated by amyloidosis Neutropenia <1000 PN / mm3 Thrombocytopenia <70,000 / mm3 Hepatic impairment: bilirubin> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N Renal impairment defined by creatinine clearance <50 ml / min History of other malignancies with the exception of basal cell carcinoma and stage I cervical cancer Severe active infection Active infection with known hepatitis B or C virus. Patient with insulin-dependent or non-insulin-dependent diabetes mellitus. Intolerance or known allergy to any of the study drugs or any of its analogues Psychiatric illness that may interfere with participation in the study Patient under safeguard of justice Intellectual inability to sign informed consent Persons protected by law
