Status:
RECRUITING
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Cyceron
Conditions:
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 9 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03832127
Start Date
September 9 2022
End Date
September 9 2026
Last Update
June 14 2024
Active Locations (7)
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1
CHU d'Angers
Angers, France, 49100
2
CHU de Brest
Brest, France, 29000
3
CHU de Caen
Caen, France, 14000
4
CHU de Nantes
Nantes, France, 44093