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Imaging Young Myeloma (IMAgerie JEune Myélome) (IMAJEM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01309334
First received: March 4, 2011
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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: 3 months and 7 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Number of lesions at diagnosis [ Time Frame: Inclusion (diagnosis) ] [ Designated as safety issue: No ]
  • diffuse disease at diagnosis [ Time Frame: Diagnosis time (inclusion) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 155
Study Start Date: February 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309334

Locations
France
Nantes University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Ministry of Health, France
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01309334     History of Changes
Other Study ID Numbers: STIC/10/03, 2010-A01382-37
Study First Received: March 4, 2011
Last Updated: January 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 19, 2013