Actively Recruiting
Exploratory Study Evaluating PET 18F-Fludarabine for Initial and End-treatment Assessment of Symptomatic Multiple Myeloma Patients Not Eligible for Bone Marrow Transplant
Led by Nantes University Hospital · Updated on 2024-06-14
35
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
C
Cyceron
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 18F-Fludarabine PET scans to detect lesions in patients with symptomatic multiple myeloma (MM) who are not candidates for autologous bone marrow transplantation. This exploratory Phase 1 study aims to compare the sensitivity of 18F-Fludarabine PET to standard imaging methods like FDG-PET and MRI at initial diagnosis and to assess its usefulness at the end of treatment. The study is sponsored by Nantes University Hospital and focuses on patients receiving first-line therapy for MM. Participants will undergo two PET scans using 18F-Fludarabine: one before starting treatment and one at the end of their therapy. The study monitors the detection and evaluation of bone and other lesions through these scans. The goal is to investigate the diagnostic value and prognostic impact of 18F-Fludarabine PET compared to existing imaging techniques, including correlations with cytogenetic data and FDG uptake. During the study, researchers will assess the sensitivity, specificity, and predictive values of 18F-Fludarabine PET scans before and after treatment. Patients will have blood tests, pregnancy tests if applicable, and clinical evaluations such as Karnofsky or ECOG performance status assessments. The study includes monitoring for tolerance to 18F-Fludarabine and its correlation with disease markers. Participation duration varies, with imaging and clinical assessments conducted at baseline and treatment completion, followed by safety and outcome evaluations.
CONDITIONS
Brief Title
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic multiple myeloma in first-line treatment for patients not eligible for autologous bone marrow transplantation
- Eligible for standard treatments recommended for non-autograft patients according to ESMO guidelines
- Measurable disease by serum monoclonal component or free light chain levels (serum or urine)
- Affiliated with a social insurance scheme
- Able to understand and voluntarily sign informed consent
- Women of childbearing potential must have a negative serum pregnancy test within 2 days before each PET scan
- Women of childbearing potential must use effective contraception during the study and for 30 days after the last PET
- Male patients with pregnant partners or partners of childbearing potential must use condoms and spermicide until 90 days after the last PET
- Known negative HIV serology
- Karnofsky performance score of 70 or higher or ECOG status 0-1
You will not qualify if you...
- Under 18 years of age
- Pregnant or breastfeeding
- Refusal to follow birth control requirements
- Primary AL amyloidosis or myeloma complicated by amyloidosis
- Neutropenia with less than 1000 PN/mm3
- Thrombocytopenia with less than 70,000/mm3
- Liver impairment with bilirubin over 35 µmol/L or elevated liver enzymes above 3 times normal
- Kidney impairment with creatinine clearance less than 50 ml/min
- History of other cancers except basal cell carcinoma or stage I cervical cancer
- Severe active infection
- Active hepatitis B or C infection
- Diabetes mellitus, insulin-dependent or not
- Known allergy or intolerance to study drugs or analogues
- Psychiatric illness interfering with study participation
- Under legal protection or safeguard of justice
- Unable to provide informed consent
- Persons legally protected by law
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of initial treatment period
Participants undergo two PET scans with 18F-Fludarabine: one at baseline before treatment and another at the end of treatment to assess multiple myeloma lesions.
2 visits (in-person)
Trial Site Locations
Total: 7 locations
1
CHU d'Angers
Angers, France, 49100
Actively Recruiting
2
CHU de Brest
Brest, France, 29000
Actively Recruiting
3
CHU de Caen
Caen, France, 14000
Actively Recruiting
4
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
5
Centre Eugène Marquis
Rennes, France, 35000
Withdrawn
6
CHU de Rennes
Rennes, France, 35000
Withdrawn
7
CHU de Tours
Tours, France, 37000
Actively Recruiting
Research Team
C
Caroline Bodet-Milin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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