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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03832127
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nantes University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloma
Arms & Interventions

Arms

Experimental: Fludatep

PET with 18F-Fludarabine

Interventions

Drug: - 18F-Fludarabine

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU d'Angers, Angers, France

Status

Address

CHU d'Angers

Angers, , 49100

Site Contact

Pacôme Fosse, MD

caroline.milin@chu-nantes.fr

33240084136

CHU de Brest, Brest, France

Status

Address

CHU de Brest

Brest, , 29000

Site Contact

Pierre Yves Salaün, MD

caroline.milin@chu-nantes.fr

33240084136

CHU de Caen, Caen, France

Status

Address

CHU de Caen

Caen, , 14000

Site Contact

Nicolas Aide, MD

caroline.milin@chu-nantes.fr

33240084136

CHU de Nantes, Nantes, France

Status

Address

CHU de Nantes

Nantes, , 44093

Site Contact

Caroline Bodet-Milin, MD

caroline.milin@chu-nantes.fr

33240084136

Centre Eugène Marquis, Rennes, France

Status

Address

Centre Eugène Marquis

Rennes, , 35000

Site Contact

Anne Devillers, MD

caroline.milin@chu-nantes.fr

33240084136

CHU de Rennes, Rennes, France

Status

Address

CHU de Rennes

Rennes, , 35000

Site Contact

Thierry Lamy, MD

caroline.milin@chu-nantes.fr

33240084136

CHU de Tours, Tours, France

Status

Address

CHU de Tours

Tours, , 37000

Site Contact

Maria Joao Santiago-Ribeiro, MD

caroline.milin@chu-nantes.fr

33240084136