NCT03832127RecruitingPhase 1
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
Nantes University Hospital7 sites in 1 country35 target enrollmentStarted: September 9, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 35
- Locations
- 7
- Primary Endpoint
- Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fludatep
Experimental
PET with 18F-Fludarabine
Intervention: 18F-Fludarabine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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 FludaTEP on the initial assessment and for the end-of-treatment therapeutic evaluation(Before and After treatment)
- 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 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)
- 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(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)
Investigators
Study Sites (7)
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