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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 7 центров

• 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

Идентификаторы

NCT: NCT03832127 · RC18_0055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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