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NCT Number: NCT01309334

Imaging Young Myeloma (IMAgerie JEune Myélome)

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bordeaux University Hospital, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET Scan

Procedure

Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy

MRI

Procedure

Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy

Primary outcomes

  1. Number of patients with at least one lesion not detected on the MRI lesions

    Time frame: At diagnosis

Secondary outcomes

  1. Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment

    Time frame: 3 months and 7 months

  2. Number of lesions at diagnosis

    Time frame: Inclusion (diagnosis)

  3. diffuse disease at diagnosis

    Time frame: Diagnosis time (inclusion)

  4. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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.

Acronym: IMAJEM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2011
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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