Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-01 @ 11:00 PM
Study NCT ID:
NCT06324266
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'C015575', 'term': 'vicilin protein, plant'}], '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'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS1', 'timeFrame': '3 years', 'description': 'Progression-free Survival 1'}], 'secondaryOutcomes': [{'measure': 'Incidence of Efficacy as assessed by IMWG', 'timeFrame': '3 years', 'description': 'Efficacy assessed by IMWG'}, {'measure': 'Incidence of Safety as assessed by CTCAE 4.0', 'timeFrame': '3 years', 'description': 'Safety assessed by CTCAE 4.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Newly Diagnosed Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.', 'detailedDescription': 'The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. After induction and consolidation therapy (8 courses of chemotherapy), MM patients in the standard-risk group who were initially unsuitable for transplantation achieved a therapeutic effect of VGPR or above;\n2. Secretory MM with measurable indicators;\n3. Age ≥ 18 years old, gender unlimited;\n4. No obvious dysfunction of heart, lungs, etc. (≤ Grade I);\n5. General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).\n\nExclusion Criteria:\n\n1. Cytogenetic high-risk patients;\n2. Recurrent or refractory MM;\n3. Using autologous hematopoietic stem cell transplantation as a consolidation therapy;\n4. The therapeutic effect did not reach VGPR or above before enrollment;\n5. Asymptomatic MM;\n6. No measurable indicators;\n7. KPS\\<50%(excluding those caused by pathological fractures）；\n8. Dysfunction of heart, lungs, etc. (\\> Grade I);\n9. Unable to cooperate in observing adverse reactions and therapeutic effects;\n10. Pregnancy, breastfeeding, or refusal of contraception by women;\n11. There is drug abuse and medical, psychological, or social conditions that may interfere with patients participating in research or evaluating research results;\n12. Any unstable or potentially endangering patient safety and compliance with the study.'}, 'identificationModule': {'nctId': 'NCT06324266', 'briefTitle': 'Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation', 'orgStudyIdInfo': {'id': '2023NZKY-044-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arm CTX', 'description': 'Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years', 'interventionNames': ['Drug: Cyclophosphamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'arm Len', 'description': 'Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years', 'interventionNames': ['Drug: Lenalidomide']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': 'Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Cyclophosphamide monotherapy for 2 years.', 'armGroupLabels': ['arm CTX']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Len'], 'description': 'Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy and are not suitable transplantation, are maintained with Lenalidomide monotherapy for 2 years.', 'armGroupLabels': ['arm Len']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhao Qian', 'role': 'CONTACT', 'email': '540598707@qq.com', 'phone': '18251835035'}], 'facility': 'Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhao Qian', 'role': 'CONTACT', 'email': '540598707@qq.com', 'phone': '18251835035'}], 'overallOfficials': [{'name': 'Li Feng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hematology of Jinling Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Feng Li', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}