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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Cyceron
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

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