Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT05164250
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2025-11-10
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Relapsed, Refractory'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': "Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma", 'detailedDescription': 'Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05164250', 'briefTitle': 'Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R5458-MM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'REGN5458', 'type': 'DRUG', 'otherNames': ['BCMAxCD3', 'linvoseltamab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}