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

Nantes University Hospital (NUH)

Status and phase

Enrolling

Phase 1

Conditions

Myeloma

Treatments

Drug: 18F-Fludarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT03832127

RC18_0055

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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