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

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ClinicalTrials.gov Identifier: NCT03832127
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
Cyceron
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Myeloma Drug: 18F-Fludarabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Fludatep
PET with 18F-Fludarabine
Drug: 18F-Fludarabine
Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma




Primary Outcome Measures :
  1. Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP) [ Time Frame: Before treatment ]

    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.



Secondary Outcome Measures :
  1. 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 ]

    The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial assessment will be assessed through an optimal reading mode lesion analysis (ie by consensus of experts) using same true positive and false positive définitions as for the main endpoint and defining: -positive lesion with 18F-Fludarabine but not found or confirmed on an histological examination, or other imaging technique (PET-FDG, MRI +/- Scan) or at follow-up

    True negative:

    -negative lesion with 18F-Fludarabine and negative with FDG-PET and MRI


  2. 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 ]
    The specificity, positive predictive value (PPV) and negative predictive value (NPV) of the FludaTEP for the initial balance will be evaluated through lesion analysis based on the local reading investigator center reading using definitions of VP, VN, FP, and FN described above.

  3. 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 ]
    The prognostic impact of FDG-PET and FludaTEP as a function of the number of lesions detected by each imaging technique will be evaluated by evaluating the impact of these data on progression-free survival and overall survival. Progression-free survival is defined as the time between the beginning of treatment of the disease and relapse or progression. Overall survival is defined as the time between the start of treatment and death.

  4. 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 ]
    The prognostic impact of FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation will be determined by evaluating the impact of a decrease and a negation of the signal in imaging on an increase in progression-free survival and overall survival.

  5. 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 ]
    Correlations between the 18Fludarabine and FDG uptake intensities assessed by SUVs and the quantitative expression of markers measured in flow cytometry and cytogenetic data (in particular the expression of the coding gene for hexokinases) will be measured using Spearman's correlation coefficient.

  6. 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 ]
    Tolerance to 18F-Fludarabine will be evaluated by clinical monitoring during 2 hours following the 18F-Fludarabine injection. Clinical data will be taken prior to the 18F-Fludarabine injection, prior to the data capture at 60min and after the last data capture.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832127


Contacts
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Contact: Caroline Bodet-Milin, MD 33240084136 caroline.milin@chu-nantes.fr

Locations
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France
CHU d'Angers
Angers, France, 49100
Contact: Pacôme Fosse, MD         
Principal Investigator: Pacôme Fosse, MD         
CHU de Brest
Brest, France, 29000
Contact: Pierre Yves Salaün, MD         
Principal Investigator: Pierre Yvese Salaün, MD         
CHU de Caen
Caen, France, 14000
Contact: Nicolas Aide, MD         
Principal Investigator: Nicolas Aide, MD         
CHU de Nantes
Nantes, France, 44093
Contact: Caroline Bodet-Milin, MD         
Principal Investigator: Caroline bodet Mion, MD         
Centre Eugène Marquis
Rennes, France, 35000
Contact: Anne Devillers, MD         
Principal Investigator: Anne Devillers, MD         
CHU de Rennes
Rennes, France, 35000
Contact: Thierry Lamy, MD         
Principal Investigator: Thierry Lamy, MD         
CHU de Tours
Tours, France, 37000
Contact: Maria Joao Santiago-Ribeiro, MD         
Principal Investigator: Maria Joao Santiago-Ribeiro, MD         
Sponsors and Collaborators
Nantes University Hospital
Cyceron
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03832127    
Other Study ID Numbers: RC18_0055
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Antineoplastic Agents