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

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

Recruiting
18 years and older
All
Phase 1

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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.

Eligibility

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

Study details
    Myeloma

NCT03832127

Nantes University Hospital

22 June 2024

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