Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-15 @ 4:39 AM
Study NCT ID:
NCT02976493
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2016-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan', 'timeFrame': 'Up to 72 weeks', 'description': 'immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.'}, {'measure': 'Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}, {'measure': 'Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria', 'timeFrame': 'Up to 72 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at healthcare facilities in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study\n\nExclusion Criteria:\n\n* Not Applicable'}, 'identificationModule': {'nctId': 'NCT02976493', 'briefTitle': 'Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CA204-179'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MM patients receiving elotuzumab', 'description': 'Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['MM patients receiving elotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '162-0822', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}