Ignite Creation Date:
2025-12-24 @ 3:46 PM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01021592
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2009-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Multiple Myeloma Patients Treated With Bortezomib
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': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-22', 'studyFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib', 'timeFrame': 'Before the first, after the fourth and at the last IV cycle of bortezomib'}], 'secondaryOutcomes': [{'measure': 'Relationship between the primary outcome and the complete remission (CR) rate', 'timeFrame': 'Before the first, after the fourth and at the last IV cycle of bortezomib'}, {'measure': 'Relationship between the primary outcome and the overall response rate', 'timeFrame': 'Before the first, after the fourth and at the last IV cycle of bortezomib'}, {'measure': 'Relationship between the primary outcome and the time to response', 'timeFrame': 'Before the first, after the fourth and at the last IV cycle of bortezomib'}, {'measure': 'Adverse events', 'timeFrame': 'Every 3 week cycle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Velcade', 'QoL', 'Proteasome inhibitor', 'Bortezomib', 'EORTC QLQ C30', 'EQ 5D'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=312&filename=CR012961_CSR.pdf', 'label': 'Evaluation in Improvement of Quality of Life in Patients with Multiple Myeloma Using Velcade® (bortezomib)'}]}, 'descriptionModule': {'briefSummary': 'This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.', 'detailedDescription': 'Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma\n* Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included\n\nExclusion Criteria:\n\n* Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity\n* Patients with severe hepatic impairment\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01021592', 'briefTitle': 'Quality of Life in Multiple Myeloma Patients Treated With Bortezomib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Korea, Ltd., Korea'}, 'officialTitle': 'Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study', 'orgStudyIdInfo': {'id': 'CR012961'}, 'secondaryIdInfos': [{'id': 'BOR-KOR-11'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'interventionNames': ['Drug: bortezomib']}], 'interventions': [{'name': 'bortezomib', 'type': 'DRUG', 'description': 'Injection into a vein 1.3 mg/m2 twice a week for 21 days', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen Korea, Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Korea, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Korea, Ltd., Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}