Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 5:16 AM
Study NCT ID:
NCT06359067
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Study of Bispecific Antibodies in 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection rate', 'timeFrame': 'Up to 18 months', 'description': 'Explore the infection rate'}], 'secondaryOutcomes': [{'measure': 'Global survival', 'timeFrame': 'Up to 18 months', 'description': 'Explore the global survival'}, {'measure': 'Progression-free survivals', 'timeFrame': 'Up to 18 months', 'description': 'Explore the progression-free survivals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'Teclistamab', 'Elranatamab', 'Bispecific antibody'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).', 'detailedDescription': 'Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 years old\n* Patients with multiple myeloma\n* Patients who received at least one administration of the following therapies: teclistamab, elranatamab\n\nExclusion Criteria:\n\n\\- Patients opposed to the collection of their personal data'}, 'identificationModule': {'nctId': 'NCT06359067', 'acronym': 'BISPEMM', 'briefTitle': 'A Real-World Study of Bispecific Antibodies in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'APHP240295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treated by bispecific antibodies', 'description': 'Patients with multiple myeloma, penta-drug or triple class refractory and treated by bispecific antibodies, teclistamab or elranatamab', 'interventionNames': ['Other: Treated by bispecific antibodies, teclistamab or elranatamab in usual care']}, {'label': 'Control group', 'description': 'Patients with multiple myeloma, penta-drug or triple class refractory and not treated by bispecific antibodies', 'interventionNames': ['Other: Not treated by bispecific antibodies in usual care']}], 'interventions': [{'name': 'Treated by bispecific antibodies, teclistamab or elranatamab in usual care', 'type': 'OTHER', 'description': 'Treated by bispecific antibodies, teclistamab or elranatamab in usual care', 'armGroupLabels': ['Treated by bispecific antibodies']}, {'name': 'Not treated by bispecific antibodies in usual care', 'type': 'OTHER', 'description': 'Not treated by bispecific antibodies in usual care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'state': 'IDF', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jeremie ZERBIT, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}