Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-27 @ 4:01 AM
Study NCT ID:
NCT05289492
Status:
TERMINATED
Last Update Posted:
2024-10-26
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Novel Regimens in Relapsed 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': 'C000624220', 'term': 'iberdomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Company operational decision. Decision to stop study is not due to safety or efficacy concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-18', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with any adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From first study treatment administration up to 120 days after the last dose'}, {'measure': 'Number of participants with dose limiting toxicity (DLT)', 'timeFrame': 'From first study treatment administration up to 120 days after the last dose'}, {'measure': 'Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma', 'timeFrame': 'up to 2 years'}, {'measure': 'Number of participants with overall response (partial or better) as determined by IMWG criteria', 'timeFrame': 'up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free-survival (PFS)', 'timeFrame': 'Until disease progression or death - Approximately 24 months'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Until disease progression or death - Approximately 24 months'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Approximately 48 weeks'}, {'measure': 'Maximum concentration (Cmax) of EOS884448 at each dose level', 'timeFrame': 'Approximately 48 weeks'}, {'measure': 'Percentage of participants with anti-drug antibodies to EOS884448', 'timeFrame': 'Approximately 48 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'EOS884448', 'GSK4428859A', 'TIGIT', 'Anti-TIGIT', 'iberdomide', 'CELMoD', 'CC-220', 'EOS-448', 'Belrestotug'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.\n* All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).\n* All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.\n* All participants must have adequate organ function.\n* Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.\n\nExclusion Criteria:\n\n* All participants with non-secretory MM\n* All participants with known auto-immune disease\n* All participants with history of life-threatening toxicity related to prior immune therapy.\n* All participants with active graft versus host disease after allogeneic stem cell transplantation.\n* All participants with active, unstable cardiovascular function.\n* All participants with active infection requiring systemic therapy.\n* All participants with hypersensitivity to any of the treatments.\n* All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.'}, 'identificationModule': {'nctId': 'NCT05289492', 'briefTitle': 'Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'iTeos Therapeutics'}, 'officialTitle': 'Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'TIG-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Participants will receive EOS884448', 'description': 'EOS884448 will be administered', 'interventionNames': ['Drug: EOS884448']}, {'type': 'EXPERIMENTAL', 'label': 'B: Participants will receive EOS884448 and iberdomide', 'description': 'EOS884448 and iberdomide will be administered', 'interventionNames': ['Drug: EOS884448', 'Drug: Iberdomide']}, {'type': 'EXPERIMENTAL', 'label': 'C: Participants will receive EOS884448, iberdomide and dexamethasone', 'description': 'EOS884448, iberdomide and dexamethasone will be administered', 'interventionNames': ['Drug: EOS884448', 'Drug: Iberdomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'EOS884448', 'type': 'DRUG', 'otherNames': ['EOS-448, GSK4428859A, Belrestotug'], 'description': 'EOS884448 will be administered in arm A,B and C', 'armGroupLabels': ['A: Participants will receive EOS884448', 'B: Participants will receive EOS884448 and iberdomide', 'C: Participants will receive EOS884448, iberdomide and dexamethasone']}, {'name': 'Iberdomide', 'type': 'DRUG', 'otherNames': ['CC-220'], 'description': 'Iberdomide will be administered in arm B and C', 'armGroupLabels': ['B: Participants will receive EOS884448 and iberdomide', 'C: Participants will receive EOS884448, iberdomide and dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone will be administered in arm C', 'armGroupLabels': ['C: Participants will receive EOS884448, iberdomide and dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology & Oncology', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Cadix', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'APHP Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Iteos Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'iTeos Belgium SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iTeos Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'iTeos Belgium SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}