Multiple Myeloma
Conditions
Keywords
MRI, PET-scan, multiple myeloma, prognosis, pharmacoeconomic analysis
Brief summary
Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.
Interventions
PROCEDUREPET scan
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
PROCEDUREMRI
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
Sponsors
Nantes University Hospital
Ministry of Health, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic de novo multiple myeloma * less than 65 years of age * enrolled in the IFM/DFCI clinical trial
Exclusion criteria
* 66 years of age or more * not eligible for high-dose therapy * Cons-indications to MRI or PET-Scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with at least one lesion not detected on the MRI lesions | At diagnosis |
Secondary
| Measure | Time frame |
|---|---|
| Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment | 3 months and 7 months |
| Number of lesions at diagnosis | Inclusion (diagnosis) |
| diffuse disease at diagnosis | Diagnosis time (inclusion) |
| Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment | Inclusion, 3 months and 7 months |
Countries
France
Outcome results
None listed