Imaging Young Myeloma (IMAgerie JEune Myélome)

NCT ID: NCT01309334

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PET scan

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

Intervention Type PROCEDURE

MRI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux University Hospital

Bordeaux, , France

Site Status

Brest University Hospital "CHU du Morvan"

Brest, , France

Site Status

Hospital "Côte de Nacre"

Caen, , France

Site Status

Clermont-Ferrand University Hospital

Clermont-Ferrand, , France

Site Status

Dijon University Hospital

Dijon, , France

Site Status

Grenoble University Hospital "Hôpital Michallon"

Grenoble, , France

Site Status

Le Mans Hospital

Le Mans, , France

Site Status

Lille University Hospital "Claude Huriez"

Lille, , France

Site Status

Lyon University Hospital

Lyon, , France

Site Status

"Institut Paoli Calmettes"

Marseille, , France

Site Status

Metz University Hospital "Hôpital de Mercy"

Metz, , France

Site Status

Nancy University Hospita "Hôpitaux de Brabois"

Nancy, , France

Site Status

Nantes University Hospital

Nantes, , France

Site Status

APHP "Hôpital Saint-Antoine"

Paris, , France

Site Status

Rennes University Hospital

Rennes, , France

Site Status

Toulouse University Hospital

Toulouse, , France

Site Status

Tours University Hospital "Hôpital Bretonneau"

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33151787 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33006656 (View on PubMed)

Other Identifiers

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2010-A01382-37

Identifier Type: OTHER

Identifier Source: secondary_id

STIC/10/03

Identifier Type: -

Identifier Source: org_study_id

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