Imaging Young Myeloma (IMAgerie JEune Myélome)

Phase 3

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT01309334
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with at least one lesion not detected on the MRI lesions	At diagnosis

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (17)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Hospital "Côte de Nacre"; 🇫🇷 Caen, France

Brest University Hospital "CHU du Morvan"; 🇫🇷 Brest, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Dijon University Hospital; 🇫🇷 Dijon, France

Lille University Hospital "Claude Huriez"; 🇫🇷 Lille, France

Le Mans Hospital; 🇫🇷 Le Mans, France

Lyon University Hospital; 🇫🇷 Lyon, France

"Institut Paoli Calmettes"; 🇫🇷 Marseille, France

Nantes University Hospital; 🇫🇷 Nantes, France

Metz University Hospital "Hôpital de Mercy"; 🇫🇷 Metz, France

Nancy University Hospita "Hôpitaux de Brabois"; 🇫🇷 Nancy, France

APHP "Hôpital Saint-Antoine"; 🇫🇷 Paris, France

Rennes University Hospital; 🇫🇷 Rennes, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Tours University Hospital "Hôpital Bretonneau"; 🇫🇷 Tours, France

Grenoble University Hospital "Hôpital Michallon"; 🇫🇷 Grenoble, France