Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06153251
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess BMS-986453 in Participants With Relapsed and/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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-05-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-emergent adverse events (AEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with AEs leading to death', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 4 years'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Complete response rate (CRR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Number of participants with very good partial response (VGPR) or better', 'timeFrame': 'Up to 4 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Time to complete response (TTCR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of complete response (DOCR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Persistence of BMS-986453 in peripheral blood', 'timeFrame': 'Up to 4 years', 'description': 'Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)'}, {'measure': 'Expansion rate', 'timeFrame': 'Up to 4 years', 'description': 'Defined as Cmax divided by Tmax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual Targeting', 'BCMAxGPRC5D', 'GPRC5DxBCMA', 'BMS-986453', 'CAR T', 'CART', 'Multiple Myeloma', 'Relapsed and/or Refractory'], 'conditions': ['Relapsed and/or Refractory Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06153251.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.\n* Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.\n* Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.\n* Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.\n* Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT06153251', 'briefTitle': 'A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Juno Therapeutics, Inc., a Bristol-Myers Squibb Company'}, 'officialTitle': 'A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CA119-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of BMS-986453', 'interventionNames': ['Drug: BMS-986453', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'BMS-986453', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of BMS-986453']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of BMS-986453']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Administration of BMS-986453']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Luciano Costa, Site 0001', 'role': 'CONTACT', 'phone': '205-934-9695'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'MURALI JANAKIRAM, Site 0003', 'role': 'CONTACT', 'phone': '626-201-5710'}], 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alfred Chung, Site 0011', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'UCSF Helen Diller Medical Center at Parnassus Heights', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Surbhi Sidana, Site 0006', 'role': 'CONTACT', 'phone': '650-723-0822'}], 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tara Gregory, Site 0013', 'role': 'CONTACT', 'phone': '720-754-4800'}], 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Noffar Bar, Site 0005', 'role': 'CONTACT', 'phone': '000-000-0000'}], 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Doris Hansen, Site 0016', 'role': 'CONTACT', 'phone': '601-812-3214'}], 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clifton Mo, Site 0023', 'role': 'CONTACT', 'phone': '202-689-9961'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adriana Rossi, Site 0010', 'role': 'CONTACT', 'phone': '646-962-6500'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sham Mailankody, Site 0004', 'role': 'CONTACT', 'phone': '646-608-3712'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0008', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0008', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jesus Berdeja, Site 0020', 'role': 'CONTACT', 'phone': '615-329-0570'}], 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Swathi Namburi, Site 0012', 'role': 'CONTACT', 'phone': '206-386-6738'}], 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand Arnulf, Site 0019', 'role': 'CONTACT', 'phone': '33142499472'}], 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christof Scheid, Site 0017', 'role': 'CONTACT', 'phone': '492214786296'}], 'facility': 'Universitaetsklinikum Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'D-69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc-Steffen Raab, Site 0021', 'role': 'CONTACT', 'phone': '496221565427'}], 'facility': 'Universitaetsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '97080', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hermann Einsele, Site 0018', 'role': 'CONTACT', 'phone': '+4994120140202'}], 'facility': 'Universitaetsklinikum Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Paula Rodriguez Otero, Site 0015', 'role': 'CONTACT', 'phone': '+0034948254000 0 000'}], 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Victoria Mateos Manteca, Site 0014', 'role': 'CONTACT', 'phone': '34923291100'}], 'facility': 'Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'BMS Study Connect www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain the NCT# and Site#', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/disclosure-commitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juno Therapeutics, Inc., a Bristol-Myers Squibb Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}