Evaluating a new imaging agent for diagnosing and assessing treatment in 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

This study is testing a new imaging agent called 18F-Fludarabine to see if it can better diagnose multiple myeloma and check how well treatment is working for patients who can't have a bone marrow transplant.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Drugs / interventions: Fludarabine
• Locations: 7 sites (Angers and 6 other locations)
• Trial ID: NCT03832127 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to assess the sensitivity of 18F-Fludarabine for the initial diagnosis of symptomatic multiple myeloma (MM) compared to traditional imaging methods like FDG-PET and MRI. It will also evaluate the effectiveness of this imaging agent at the end of treatment. The study includes patients who are not candidates for autologous bone marrow transplantation and who have measurable disease. Participants will undergo PET scans using 18F-Fludarabine to determine its diagnostic capabilities.

Who should consider this trial

Good fit: Ideal candidates are symptomatic multiple myeloma patients who are not eligible for autologous bone marrow transplantation.

Not a fit: Patients with non-symptomatic multiple myeloma or those eligible for autologous bone marrow transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective imaging method for diagnosing and monitoring treatment in multiple myeloma patients.

How similar studies have performed: While this approach is novel in evaluating 18F-Fludarabine for multiple myeloma, similar imaging studies have shown promise in other conditions.

Eligibility 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

Where this trial is running

Angers and 6 other locations

• CHU d'Angers — Angers, France (Recruiting)
• CHU de Brest — Brest, France (Recruiting)
• CHU de Caen — Caen, France (Recruiting)
• CHU de Nantes — Nantes, France (Recruiting)
• Centre Eugène Marquis — Rennes, France (Withdrawn)
• CHU de Rennes — Rennes, France (Withdrawn)
• CHU de Tours — Tours, France (Recruiting)

Study contacts

• Study coordinator: Caroline Bodet-Milin, MD

Conditions Myeloma