Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1
Nantes University Hospital (Voir sur ClinicalTrials)
septembre 2022
septembre 2026
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Eugène Marquis - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU d'Angers - 49100 - Angers - France | Pacôme Fosse, MD | Contact (sur clinicalTrials) | |||
| CHU de Brest - 29000 - Brest - France | Pierre Yves Salaün, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14000 - Caen - France | Nicolas Aide, MD | Contact (sur clinicalTrials) | |||
| CHU de Rennes - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU de Tours - 37000 - Tours - France | Maria Joao Santiago-Ribeiro, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nantes - 44093 - Nantes - France | Caroline Bodet-Milin, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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