NCT03832127 Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
| NCT ID | NCT03832127 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nantes University Hospital |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2022-09-07 |
| Primary Completion | 2029-09-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2022-09-07 with a primary completion date of 2029-09-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03832127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03832127 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03832127 currently recruiting?
Yes, NCT03832127 is actively recruiting participants. Contact the research team at caroline.milin@chu-nantes.fr for enrollment information.
Where is the NCT03832127 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Caen, France, Nantes, France and 3 additional locations.
Who is sponsoring the NCT03832127 clinical trial?
NCT03832127 is sponsored by Nantes University Hospital. The trial plans to enroll 35 participants.