Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients

Ki vehet részt

• 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

Ki nem vehet részt

• Male or female refusing birth control conditions
• 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
• Hepatic impairment: bilirubin> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
• Renal impairment defined by creatinine clearance <50 ml / min
• Age under 18 years
• Pregnancy or breastfeeding
• Primary AL amyloidosis and myeloma complicated by amyloidosis
• Neutropenia <1000 PN / mm3
• Thrombocytopenia <70,000 / mm3
• Patient under safeguard of justice
• Intellectual inability to sign informed consent
• Persons protected by law