Clinical trial NCT03832127: Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Myeloma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Cyceron
First posted: 2019-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 will also be investigated as part of the end-of-treatment therapeutic evaluation.


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

Primary outcomes:
measure: Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
timeFrame: Before treatment
Secondary outcomes:
measure: To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode.
timeFrame: Before treatment
measure: To evaluate the sensitivity, specificity, and positive and negative predictive values of the FludaTEP for the initial balance according to the local reading
timeFrame: Before treatment
measure: To evaluate the prognostic impact of FDG-PET and FludaTEP on the number of lesions detected by each imaging technique in a population of MM patients in the 1st line therapeutic but not candidates for marrow autograft.
timeFrame: After treatment
measure: To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation
timeFrame: Before and After treatment
measure: Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities
timeFrame: Before and After treatment
measure: Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities and the cytogenetic data Tolerance to 18F-Fludarabine
timeFrame: Before and After treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rennes
country: France
facility: CHU de Rennes
city: Tours
country: France
facility: CHU de Tours
Study officials:
References: