Taking peoplePhase 1
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
Key facts
- Who runs it
- Nantes University Hospital
- Where
- France7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 35 people, planned
- Started
- 7 Sept 2022
- Expected to end
- 7 Sept 2029
- Type of study
- Interventional
- Treatments tested
- 18F-Fludarabine
- Record updated
- 13 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- Male or female refusing birth control conditions
- 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
- Hepatic impairment: bilirubin> 35μmol / L and SGOT, SGPT, alkaline phosphatase greater than 3 N
- Renal impairment defined by creatinine clearance <50 ml / min
- Age under 18 years
- Pregnancy or breastfeeding
- Primary AL amyloidosis and myeloma complicated by amyloidosis
- Neutropenia <1000 PN / mm3
- Thrombocytopenia <70,000 / mm3
- Patient under safeguard of justice
- Intellectual inability to sign informed consent
- Persons protected by law
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- FludatepTreatment being tested
PET with 18F-Fludarabine
Treatment: 18F-Fludarabine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft
- Record updated
- 13 November 2026