Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT06154902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel
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': 'C000715380', 'term': 'idecabtagene vicleucel'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '15 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in France with RRMM who are eligible for treatment with, or have been treated with, idecabtagene vicleucel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel\n\nExclusion Criteria:\n\n* Not registered with the social security in France'}, 'identificationModule': {'nctId': 'NCT06154902', 'acronym': 'ABE-DESCART', 'briefTitle': 'Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'ABE-DESCART Study: Characterization and Outcomes of Patients With Relapsed and Refractory Multiple Myeloma Eligible for Treatment or Treated With Abecma© (Idecabtagene Vicleucel) in Real World Setting in France. A Database Analysis Based on the DESCAR-T Registry', 'orgStudyIdInfo': {'id': 'CA089-1041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated with idecabtagene vicleucel', 'interventionNames': ['Drug: Idecabtagene vicleucel']}, {'label': 'Eligible for idecabtagene vicleucel', 'description': 'Eligible for idecabtagene vicleucel treatment but not treated', 'interventionNames': ['Other: Not treated']}], 'interventions': [{'name': 'Idecabtagene vicleucel', 'type': 'DRUG', 'description': 'According to approved product label in France', 'armGroupLabels': ['Treated with idecabtagene vicleucel']}, {'name': 'Not treated', 'type': 'OTHER', 'description': 'Eligible for idecabtagene vicleucel treatment but not treated', 'armGroupLabels': ['Eligible for idecabtagene vicleucel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'DESCAR-T Registry', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}