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

NCT03832127 | Recruiting Phase 1 DMC

• 1 other identifier: RC18_0055
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 7

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)

  The sensitivity of the initial FludaTEP will be evaluated using an optimal reading mode lesion analysis (ie by consensus of experts) by defining : True positive: * positive lesion with 18F-Fludarabine and positive with PET-FDG or MRI * or positive lesion with 18-F-Fludarabine, negative with PET-FDG and MRI, but confirmed by further complementary imaging (CT) or histological examination, or confirmed at follow-up False negative: -negative lesion with 18F-Fludarabine and positive FDG-PET and / or MR Lesions positivity in PET-FDG and MRI will be assessed by central reading done by consensus of experts. Lesions positivity with 18F-Fludarabine will be defined by central reading assessed by 2 nuclear physicians experts in hematology with no access to the other exams' results.

  Before treatment

Secondary Outcomes (6)

• To evaluate the specificity and the positive and negative predictive values of the FludaTEP for the initial assessment through an optimal reading mode.

  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

  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.

  After treatment

• To evaluate the prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation

  Before and After treatment

• Evaluate in a population of MM patients the existence of a correlation between the 18Fludarabine and FDG uptake intensities

  Before and After treatment

Study Arms (1)

Fludatep

EXPERIMENTAL

PET with 18F-Fludarabine

Drug: 18F-Fludarabine

Interventions

18F-Fludarabine DRUG

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

Fludatep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Cyceron: collaborator

Study Sites (7)

CHU d'Angers

Angers, 49100, France

RECRUITING

CHU de Brest

Brest, 29000, France

RECRUITING

CHU de Caen

Caen, 14000, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Centre Eugène Marquis

Rennes, 35000, France

WITHDRAWN

CHU de Rennes

Rennes, 35000, France

WITHDRAWN

CHU de Tours

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Caroline Bodet-Milin, MD

CONTACT

33240084136; caroline.milin@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: February 6, 2019
• Study Start: September 9, 2022
• Primary Completion: September 9, 2024
• Study Completion (Estimated): September 9, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

FR (7)