Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
Study NCT ID:
NCT04143932
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2019-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Myeloma Turkish Prospective Patient Registry
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2019-10-27', 'studyFirstSubmitQcDate': '2019-10-27', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '[Time Frame: 5 Years]', 'description': 'Time from the diagnosis to the death'}, {'measure': 'Progression Free Survival', 'timeFrame': '[Time Frame: 5 Years]', 'description': 'Time from the initiation of treatment to the death from any cause or progression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'MM', 'Registry', 'Turkey'], 'conditions': ['Multiple Myeloma', 'Relapse Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, national, multi center, prospective multiple myeloma registry in Turkey', 'detailedDescription': 'In this study, approximately from 40 centers 1000 patients will be recruited. All patients will be followed-up till the study end.\n\nAll the laboratory results, treatment protocols and responses will be recorded and assessed with EORTC Multiple Myeloma Specific Quality of Life Multiple Myeloma Specific (MY-20) and EORTC Quality of Life-C30 questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed as multiple myeloma received maximum 2 lines of therapy will be included to this prospective registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as multiple myeloma\n* Patients signed informed consent form\n* Patients received no more then 2 lines of therapy\n\nExclusion Criteria:\n\n* Patients below 18 years old'}, 'identificationModule': {'nctId': 'NCT04143932', 'acronym': 'THD-MM-Reg', 'briefTitle': 'Multiple Myeloma Turkish Prospective Patient Registry', 'organization': {'class': 'OTHER', 'fullName': 'Turkish Hematology Association'}, 'officialTitle': 'Multiple Myeloma Patient Registry - Prospective National Multi Center Prospective Study', 'orgStudyIdInfo': {'id': 'THD-MM-Reg'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gokme Sevindik', 'role': 'CONTACT'}], 'facility': 'Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Omur Gokmen Sevindik, Assoc. Prof.', 'role': 'CONTACT', 'email': 'omurgok17@hotmail.com', 'phone': '+905427870708'}, {'name': 'Ilker Kurkcu, Pharm', 'role': 'CONTACT', 'email': 'ilker.kurkcu@sentez-cro.com', 'phone': '+905326354515'}], 'overallOfficials': [{'name': 'Omur Gokmen Sevindik, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkish Hematology Association', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}