Imaging Young Myeloma (IMAgerie JEune Myélome) (IMAJEM)

August 22, 2014 updated by: Nantes University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Bordeaux University Hospital
      • Brest, France
        • Brest University Hospital "CHU du Morvan"
      • Caen, France
        • Hospital "Côte de Nacre"
      • Clermont-Ferrand, France
        • Clermont-Ferrand University Hospital
      • Dijon, France
        • Dijon University Hospital
      • Grenoble, France
        • Grenoble University Hospital "Hôpital Michallon"
      • Le Mans, France
        • Le Mans Hospital
      • Lille, France
        • Lille University Hospital "Claude Huriez"
      • Lyon, France
        • Lyon University Hospital
      • Marseille, France
        • "Institut Paoli Calmettes"
      • Metz, France
        • Metz University Hospital "Hôpital de Mercy"
      • Nancy, France
        • Nancy University Hospita "Hôpitaux de Brabois"
      • Nantes, France, 44000
        • Nantes University Hospital
      • Paris, France
        • APHP "Hôpital Saint-Antoine"
      • Rennes, France
        • Rennes University Hospital
      • Toulouse, France
        • Toulouse University Hospital
      • Tours, France
        • Tours University Hospital "Hôpital Bretonneau"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with at least one lesion not detected on the MRI lesions
Time Frame: At diagnosis
At diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
Time Frame: 3 months and 7 months
3 months and 7 months
Number of lesions at diagnosis
Time Frame: Inclusion (diagnosis)
Inclusion (diagnosis)
diffuse disease at diagnosis
Time Frame: Diagnosis time (inclusion)
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
Inclusion, 3 months and 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Ministry of Health, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 2011

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STIC/10/03
  • 2010-A01382-37 (Other Identifier: Afssaps)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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