Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:27 PM
Study NCT ID:
NCT06744894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SIL as Maintenance Therapy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548400', 'term': 'ixazomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D008283', 'term': 'Maintenance'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 years', 'description': 'PFS was defined as the time from study entry until disease progression'}], 'secondaryOutcomes': [{'measure': 'EFS', 'timeFrame': '2 years', 'description': 'EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.'}, {'measure': 'OS', 'timeFrame': '2 years', 'description': 'OS was defined as the time from treatment initiation to death by any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.', 'detailedDescription': 'The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;\n* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;\n* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;\n* Documented response to ASCT (PR, VGPR, CR/stringent complete response \\[sCR\\]) according to IMWG criteria.\n\nExclusion Criteria:\n\n* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.\n* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT06744894', 'briefTitle': 'SIL as Maintenance Therapy in Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Selinexor Combined With Ixazomib and Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'SIL2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maintenance Therapy', 'description': 'Patients were treated by Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy', 'interventionNames': ['Drug: Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy']}], 'interventions': [{'name': 'Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy', 'type': 'DRUG', 'description': 'Patients were treated by Selinexor (40mg po qw d1-28) combined with Ixazomib (4mg po on days 1, 8, and 15 in 28-day cycles) and Lenalidomide(10mg po qd d1-21) as Maintenance Therapy.', 'armGroupLabels': ['Maintenance Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liren Qian, PhD', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066947194'}, {'name': 'Liren Qian', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Liren Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician, Associate Professor', 'investigatorFullName': 'Liren Qian', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}