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

Launched by NANTES UNIVERSITY HOSPITAL · Feb 4, 2019

Keywords

ClinConnect Summary

This clinical trial, called "Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients," is studying a new imaging method to help diagnose and evaluate treatment for multiple myeloma, a type of blood cancer. Researchers want to see how well a special substance called 18F-Fludarabine works compared to other imaging techniques like FDG-PET and MRI. The trial aims to help doctors better understand how to assess this disease at the beginning and end of treatment.

To participate in this study, you must be between 65 and 74 years old and have symptomatic multiple myeloma that cannot be treated with a specific procedure called autologous bone marrow transplantation. You also need to be eligible for standard treatments recommended for your condition. Participants will undergo imaging scans and may need to follow specific guidelines, such as using birth control if they are of childbearing potential. As always, before joining, you’ll need to review and sign an informed consent form to ensure you understand what the study involves. This trial is currently recruiting participants, and your involvement could contribute to valuable insights into treating multiple myeloma.

Gender

ALL

Eligibility 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