Multiple myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: FLUCIS 250 MBq/mL
Pharmaceutical Form: Solution for injection
Trade Name: PROSTATEP 500 MBq/mL, solution injectable
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Symptomatic Multiple Myeloma on first-line treatment as defined by 2014 International Myeloma Working Group criteria - Measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay - Age > 18 years old at time of signed consent - Beneficiary of social security insurance - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Previous Multiple Myeloma treatment - Previous cancer with less than 5 year of complete remission (including plasmacytoma) - Chemotherapy in the 6 months preceding the inclusion - Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging - Uncontrolled diabetes mellitus - Medullary growth factor injection less than 48 hours before imaging procedures - Pregnant or nursing (lactating) women - Childbearing potential woman without adequate barrier contraception method (HAS criteria) - PET contraindication - MRI contraindication Exclusion criteria after signed consent: - Positive plasmatic ßHCG test before FCH-PET - Blood glucose > 2,8 g/l before FDG-PET
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare FCH-PET and FDG-PET for the number of bone lesions detected and confirmed by reference test in patients with newly diagnosed MM and not yet treated;Secondary Objective: - To compare diagnostic performances of FCH-PET and FDG-PET within each skeleton area defined as followed : skull, spine, pelvis, ribssternum, upper limbs, lower limbs, to MRI in patients with newly diagnosed MM. - To compare diagnostic performances of FCH-PET and FDG-PET in extramedullary lesions detection in patients with newly diagnosed MM.;Primary end point(s): Number of bone lesions detected with both FCH-PET and FDG-PET;Timepoint(s) of evaluation of this end point: Visit 1 (Inclusion) Visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Diagnostic performance of FCH-PET and FDG-PET - Number of extra-medullary lesions detected with both FCH-PET and FDG-PET;Timepoint(s) of evaluation of this end point: Visit 1 (inclusion) Visit 2 | — |
Countries
France
Contacts
Public ContactResponsable d'Etudes Cliniques
CHU de Bordeaux
Outcome results
None listed