Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 3:38 PM
Study NCT ID:
NCT05248633
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2022-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'event-free survival', 'timeFrame': '2 years', 'description': 'EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years', 'description': 'OS was calculated from randomization to death'}, {'measure': 'response rate', 'timeFrame': '2 years', 'description': 'assessed according to M protein level, RECIST 1.1 and PET-CT'}, {'measure': 'adverse events', 'timeFrame': 'collected until 30 days after treatment completion', 'description': 'graded according to CTCAE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solitary Plasmacytoma']}, 'descriptionModule': {'briefSummary': 'Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treatment-naïve SP.\n\nExclusion Criteria:\n\n* Not appropriate for radiotherapy.\n* ECOG \\> 2.\n* Co-morbidity of uncontrolled infection.\n* Co-morbidity of other active malignancy.\n* Patients in pregnancy or lactation.\n* Prior or concurrent pulmonary embolism.\n* Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.\n* Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA \\> 1000 copies/mL.\n* Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.\n* Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.\n* Neutrophil \\<1×10E9/L，hemoglobin \\< 8g/dL，or platelet \\< 75×10E9/L.\n* Severely compromised hepatic or renal function: ALT or AST \\> 3 × ULN, total bilirubin \\> 1.5 × ULN，or eGFR \\< 40mL/min.'}, 'identificationModule': {'nctId': 'NCT05248633', 'briefTitle': 'Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma', 'orgStudyIdInfo': {'id': 'SP2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiotherapy', 'interventionNames': ['Radiation: radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy combined with radiotherapy', 'interventionNames': ['Radiation: radiotherapy', 'Drug: Bortezomib Injection', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'radiotherapy with a dose of 40-50 Gy', 'armGroupLabels': ['Chemotherapy combined with radiotherapy', 'Radiotherapy']}, {'name': 'Bortezomib Injection', 'type': 'DRUG', 'description': 'subcutaneous Bortezomib 1.3mg/m2 d1,8,15,22', 'armGroupLabels': ['Chemotherapy combined with radiotherapy']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Lenalidomide 25mg for 21 days', 'armGroupLabels': ['Chemotherapy combined with radiotherapy']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 40mg d1,8,15,22', 'armGroupLabels': ['Chemotherapy combined with radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Li', 'role': 'CONTACT', 'email': 'lijian@pumch.cn', 'phone': '010-69155020'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}