Actively Recruiting
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
Led by Nantes University Hospital · Updated on 2024-06-14
35
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
C
Cyceron
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 patients receiving first-line treatment who are not candidates for autologous bone marrow transplantation
- Eligible for standard treatments recommended for patients not eligible for autograft, according to ESMO guidelines
- Multiple myeloma measurable by serum monoclonal component or free light chains in serum or urine
- Affiliated with a social insurance scheme
- Able to understand and voluntarily sign informed consent
- Women of childbearing potential must have a 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 or childbearing potential partners must use condom 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
- Pregnancy 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 liver enzymes greater than 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 infections
- Active hepatitis B or C infection
- Diabetes mellitus requiring insulin or not
- Allergy or intolerance to study drugs or analogues
- Psychiatric illness interfering with study participation
- Under legal protection or guardianship
- Unable to provide informed consent
- Persons protected by law
AI-Screening
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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
CONTACT
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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