Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-05 @ 5:33 PM
Study NCT ID:
NCT03679351
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"FU-IFM2009" Database Post IFM/DFCI 2009 Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 675}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '4 years', 'description': 'number of deaths'}], 'secondaryOutcomes': [{'measure': 'overall long-term survival', 'timeFrame': '4 years', 'description': 'number of deaths'}, {'measure': 'secondary primary malignancies', 'timeFrame': '4 years', 'description': 'number of secondary primary malignancies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been already randomized in the IFM/DFCI 2009 study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient randomized in the IFM/DFCI 2009 study.\n* Patient still alive must give their non-opposition to the post IFM/DFCI 2009 study data collection until 30 November 2020\n* Patient non-opposition.'}, 'identificationModule': {'nctId': 'NCT03679351', 'acronym': 'DB-FU-IFM2009', 'briefTitle': '"FU-IFM2009" Database Post IFM/DFCI 2009 Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': '"Follow Up-Intergroupe Francophone du Myélome 2009" Database Post IFM/DFCI 2009 Study', 'orgStudyIdInfo': {'id': 'RC31/18/221'}}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel ATTAL, PhD', 'role': 'CONTACT', 'email': 'michel.attal@iuct-oncopole.fr', 'phone': '05 31 15 50 01', 'phoneExt': '+33'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Michel ATTAL, MD PhD', 'role': 'CONTACT', 'email': 'michel.attal@iuct-oncopole.fr', 'phone': '05 31 15 50 01', 'phoneExt': '+33'}, {'name': 'Laura BOGDANOVITCH', 'role': 'CONTACT', 'email': 'bogdanovitch.l@chu-toulouse.fr', 'phone': '05 61 77 84 37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Michel Attal, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hosptial toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}