Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-05 @ 5:10 AM
Study NCT ID:
NCT01309334
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2011-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Young Myeloma (IMAgerie JEune Myélome)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-22', 'studyFirstSubmitDate': '2011-03-04', 'studyFirstSubmitQcDate': '2011-03-04', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with at least one lesion not detected on the MRI lesions', 'timeFrame': 'At diagnosis'}], 'secondaryOutcomes': [{'measure': 'Negativity of the exam after 3 cycles of chemotherapy and just before the maintenance treatment', 'timeFrame': '3 months and 7 months'}, {'measure': 'Number of lesions at diagnosis', 'timeFrame': 'Inclusion (diagnosis)'}, {'measure': 'diffuse disease at diagnosis', 'timeFrame': 'Diagnosis time (inclusion)'}, {'measure': 'Direct costs of PET and MRI at diagnosis, after the first cycles of chemotherapy and before the maintenance treatment', 'timeFrame': 'Inclusion, 3 months and 7 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'PET-scan', 'multiple myeloma', 'prognosis', 'pharmacoeconomic analysis'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '33151787', 'type': 'DERIVED', '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.'}, {'pmid': '33006656', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic de novo multiple myeloma\n* less than 65 years of age\n* enrolled in the IFM/DFCI clinical trial\n\nExclusion Criteria:\n\n* 66 years of age or more\n* not eligible for high-dose therapy\n* Cons-indications to MRI or PET-Scan'}, 'identificationModule': {'nctId': 'NCT01309334', 'acronym': 'IMAJEM', 'briefTitle': 'Imaging Young Myeloma (IMAgerie JEune Myélome)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'STIC/10/03'}, 'secondaryIdInfos': [{'id': '2010-A01382-37', 'type': 'OTHER', 'domain': 'Afssaps'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PET scan', 'type': 'PROCEDURE', 'description': 'Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy'}, {'name': 'MRI', 'type': 'PROCEDURE', 'description': 'Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'facility': 'Brest University Hospital "CHU du Morvan"', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'Hospital "Côte de Nacre"', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Clermont-Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'Dijon University Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble University Hospital "Hôpital Michallon"', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Le Mans Hospital', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital "Claude Huriez"', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Lyon University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': '"Institut Paoli Calmettes"', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Metz', 'country': 'France', 'facility': 'Metz University Hospital "Hôpital de Mercy"', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Nancy University Hospita "Hôpitaux de Brabois"', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP "Hôpital Saint-Antoine"', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'Tours University Hospital "Hôpital Bretonneau"', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}