Recruiting NCT03832127

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

Phase I Interventional Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 18F-Fludarabine.
Who it may be relevant to: Registry conditions: Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

Drug 18F-Fludarabine
Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma

Primary outcome measures

Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP) [Time frame: Before treatment]

Secondary outcome measures (6)

To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode. [Time frame: Before treatment]
To evaluate the sensitivity, specificity, and positive and negative predictive values of the FludaTEP for the initial balance according to the local reading [Time frame: Before treatment]
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. [Time frame: After treatment]
To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation [Time frame: Before and After treatment]
Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities [Time frame: Before and After treatment]
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 [Time frame: Before and After treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

France · 7 centers

CHU d'Angers — Angers
CHU de Brest — Brest
CHU de Caen — Caen
CHU de Nantes — Nantes
Centre Eugène Marquis — Rennes
CHU de Rennes — Rennes
CHU de Tours — Tours

Identifiers

NCT: NCT03832127 · RC18_0055

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗