Clinical trial · Interventional
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
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
NCT03832127CI-TRIAL-00077957MyelofludaterecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fludarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludatep
- description
- PET with 18F-Fludarabine
- interventionNames
- Drug: 18F-Fludarabine
Primary outcomes (1)
- measure
- Detection of sensitivity of the lesions (osseous and extra-osseous) of 18Fludarabine PET (FludaTEP)
- timeFrame
- Before treatment
- description
- 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 (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.