Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-20 @ 12:47 PM
Study NCT ID:
NCT02556905
Status:
COMPLETED
Last Update Posted:
2017-12-04
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea
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': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'Up to 6 years', 'description': 'Number of participants with adverse events'}], 'secondaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'Up to 6 years', 'description': 'Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Revlimid', 'Lenalidomide', 'Observational', 'Korea', 'Post Marketing Surveillance[PMS]'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': "The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.\n\nThe patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.\n\nTotal 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.\n\nREVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety \\& efficacy of the drug.\n\nIt is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All Korean patients who are intended to be treated with REVLIMID® and must be registered in risk management program according to the approved package insert.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Korean male or female who are diagnosed with Multiple Myeloma\n* In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®\n* Patients who are registered for Risk Management Program of Celgene\n\nExclusion Criteria:\n\n* There's no exclusion criteria"}, 'identificationModule': {'nctId': 'NCT02556905', 'briefTitle': 'A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'REVLIMID® Drug Use Examination', 'orgStudyIdInfo': {'id': 'NIPMS-RV-KR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Korean patients', 'description': 'All Korean patients intended to be treated with REVLIMID® according to the approved package insert', 'interventionNames': ['Drug: REVLIMID®', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'REVLIMID®', 'type': 'DRUG', 'description': 'The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result.', 'armGroupLabels': ['Korean patients']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'The recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days.', 'armGroupLabels': ['Korean patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14068', 'city': 'Anyang', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'zip': '14584', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-a University Medical Center', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49267', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41954', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '58128', 'city': 'Hwasun-gun', 'country': 'South Korea', 'facility': 'Hwasun Chonnam National University Hospital'}, {'zip': '54907', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '01757', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Sanggye Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07985', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '26426', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Miran Moon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}