Imaging Young Myeloma (IMAgerie JEune Myélome)

Multiple Myeloma Clinical Trial

— IMAJEM  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309334
• Other study ID #: STIC/10/03
• Secondary ID: 2010-A01382-37
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2011
• Last updated: August 22, 2014
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• PET scan
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
• MRI
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux
France	Brest University Hospital "CHU du Morvan"	Brest
France	Hospital "Côte de Nacre"	Caen
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Dijon University Hospital	Dijon
France	Grenoble University Hospital "Hôpital Michallon"	Grenoble
France	Le Mans Hospital	Le Mans
France	Lille University Hospital "Claude Huriez"	Lille
France	Lyon University Hospital	Lyon
France	"Institut Paoli Calmettes"	Marseille
France	Metz University Hospital "Hôpital de Mercy"	Metz
France	Nancy University Hospita "Hôpitaux de Brabois"	Nancy
France	Nantes University Hospital	Nantes
France	APHP "Hôpital Saint-Antoine"	Paris
France	Rennes University Hospital	Rennes
France	Toulouse University Hospital	Toulouse
France	Tours University Hospital "Hôpital Bretonneau"	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one lesion not detected on the MRI lesions		At diagnosis	No
Secondary	Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment		3 months and 7 months	No
Secondary	Number of lesions at diagnosis		Inclusion (diagnosis)	No
Secondary	diffuse disease at diagnosis		Diagnosis time (inclusion)	No
Secondary	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	No