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Imaging Young Myeloma (IMAgerie JEune Myélome) (IMAJEM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309334
First Posted: March 7, 2011
Last Update Posted: August 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Procedure: PET scan Procedure: MRI Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of patients with at least one lesion not detected on the MRI lesions [ Time Frame: At diagnosis ]

Secondary Outcome Measures:
  • Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment [ Time Frame: 3 months and 7 months ]
  • Number of lesions at diagnosis [ Time Frame: Inclusion (diagnosis) ]
  • diffuse disease at diagnosis [ Time Frame: Diagnosis time (inclusion) ]
  • Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment [ Time Frame: Inclusion, 3 months and 7 months ]

Enrollment: 152
Study Start Date: February 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PET scan
    Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
    Procedure: MRI
    Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309334


Locations
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, 44000
APHP "Hôpital Saint-Antoine"
Paris, France
Rennes University Hospital
Rennes, France
Toulouse University Hospital
Toulouse, France
Tours University Hospital "Hôpital Bretonneau"
Tours, France
Sponsors and Collaborators
Nantes University Hospital
Ministry of Health, France
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01309334     History of Changes
Other Study ID Numbers: STIC/10/03
2010-A01382-37 ( Other Identifier: Afssaps )
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Nantes University Hospital:
MRI
PET-scan
multiple myeloma
prognosis
pharmacoeconomic analysis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases