TheranosticTrials.org

Clinical Trial · NCT03832127

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

Overview

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.

Sponsor

Nantes University Hospital

Phase

Phase 1

Contacts

Caroline Bodet-Milin, MD (CONTACT)

caroline.milin@chu-nantes.fr

33240084136

ClinicalTrials.gov

NCT03832127

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Fludarabine

Isotope(s):
Target(s):
  • dCK
Ligand Class: Small Molecules

Eligibility

Inclusion

  • The patient must understand and voluntarily sign the informed consent form
  • Patient affiliated with a social insurance scheme
  • MM with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary).
  • * 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

Exclusion

  • Neutropenia \<1000 PN / mm3
  • Primary AL amyloidosis and myeloma complicated by amyloidosis
  • Pregnancy or breastfeeding
  • Male or female refusing birth control conditions
  • * Age under 18 years