Clinical trial NCT01309334: Imaging Young Myeloma (IMAgerie JEune Myélome)
Official title: Pharmacoeconomic and Clinical Prospective Comparison of PET-scan and MRI in Patients With de Novo Multiple Myeloma Less Than 65 Years of Age Treated According to IFM/DFCI 2009 Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: MRI
PET-scan
multiple myeloma
prognosis
pharmacoeconomic analysis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-03-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with at least one lesion not detected on the MRI lesions
timeFrame: At diagnosis
Secondary outcomes:
measure: Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
timeFrame: 3 months and 7 months
measure: Number of lesions at diagnosis
timeFrame: Inclusion (diagnosis)
measure: diffuse disease at diagnosis
timeFrame: Diagnosis time (inclusion)
measure: Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment
timeFrame: Inclusion, 3 months and 7 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Brest
country: France
facility: Brest University Hospital "CHU du Morvan"
city: Caen
country: France
facility: Hospital "Côte de Nacre"
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital "Hôpital Michallon"
city: Le Mans
country: France
facility: Le Mans Hospital
city: Lille
country: France
facility: Lille University Hospital "Claude Huriez"
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: "Institut Paoli Calmettes"
city: Metz
country: France
facility: Metz University Hospital "Hôpital de Mercy"
city: Nancy
country: France
facility: Nancy University Hospita "Hôpitaux de Brabois"
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: APHP "Hôpital Saint-Antoine"
city: Rennes
country: France
facility: Rennes University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tours
country: France
facility: Tours University Hospital "Hôpital Bretonneau"
Study officials:
References:
citation: Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.
citation: Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.