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Imaging Young Myeloma (IMAgerie JEune Myélome) (IMAJEM)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
PET scan
MRI
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring MRI, PET-scan, multiple myeloma, prognosis, pharmacoeconomic analysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
Number of lesions at diagnosis
diffuse disease at diagnosis
Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment

Full Information

First Posted
March 4, 2011
Last Updated
August 22, 2014
Sponsor
Nantes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01309334
Brief Title
Imaging Young Myeloma (IMAgerie JEune Myélome)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MRI, PET-scan, multiple myeloma, prognosis, pharmacoeconomic analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PET scan
Intervention Description
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
Primary Outcome Measure Information:
Title
Number of patients with at least one lesion not detected on the MRI lesions
Time Frame
At diagnosis
Secondary Outcome Measure Information:
Title
Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment
Time Frame
3 months and 7 months
Title
Number of lesions at diagnosis
Time Frame
Inclusion (diagnosis)
Title
diffuse disease at diagnosis
Time Frame
Diagnosis time (inclusion)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
Country
France
Facility Name
Brest University Hospital "CHU du Morvan"
City
Brest
Country
France
Facility Name
Hospital "Côte de Nacre"
City
Caen
Country
France
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
Country
France
Facility Name
Dijon University Hospital
City
Dijon
Country
France
Facility Name
Grenoble University Hospital "Hôpital Michallon"
City
Grenoble
Country
France
Facility Name
Le Mans Hospital
City
Le Mans
Country
France
Facility Name
Lille University Hospital "Claude Huriez"
City
Lille
Country
France
Facility Name
Lyon University Hospital
City
Lyon
Country
France
Facility Name
"Institut Paoli Calmettes"
City
Marseille
Country
France
Facility Name
Metz University Hospital "Hôpital de Mercy"
City
Metz
Country
France
Facility Name
Nancy University Hospita "Hôpitaux de Brabois"
City
Nancy
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
APHP "Hôpital Saint-Antoine"
City
Paris
Country
France
Facility Name
Rennes University Hospital
City
Rennes
Country
France
Facility Name
Toulouse University Hospital
City
Toulouse
Country
France
Facility Name
Tours University Hospital "Hôpital Bretonneau"
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33151787
Citation
Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.
Results Reference
derived
PubMed Identifier
33006656
Citation
Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.
Results Reference
derived

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Imaging Young Myeloma (IMAgerie JEune Myélome)

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