Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-02 @ 3:42 AM
Study NCT ID:
NCT04025450
Status:
RECRUITING
Last Update Posted:
2019-07-19
First Post:
2019-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this trial, patients will be randomly assigned to chidamide+VRD group or VRD group, and then treated with the corresponding regimen, and their safety and efficacy will be evaluated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2029-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': 'at the time point 1 month after the last cycle', 'description': 'complete remission rate after treated by the corresponding regimen'}, {'measure': 'incidence and severity of adverse events', 'timeFrame': "from the date of the start of treatment to 36 months after last patient's enrollment", 'description': 'any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': "from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment;", 'description': 'from date of inclusion to date of progression, relapse, or death from any cause'}, {'measure': 'overall survival', 'timeFrame': "from the day of treatment to the date of first documented progression，up to 36 months after the last patient's enrollment", 'description': 'from the date of inclusion to date of death, irrespective of cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.', 'detailedDescription': 'In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, which will be determined by efficacy and safety profiles of the patients; afterward, the optimal dosage of chidamide will be combined with VRD regimen, patients will be randomly assigned to chidamide+VRD group or VRD group, and their efficacy and safety will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Diagnosed as multiple myeloma, and has one of the above:\n\n 1. high risk karyotype, such as 17p-，t（4；14），t（14；16），t（14；20）或1q gain,1p-, double hit myeloma, triple hit myeloma, etc;\n 2. RISS-3;\n 3. IgD/IgE MM;\n 4. with measurable extra-medullary plasmacytoma;\n 5. flowcytometry showed peripheral blood plasma cell ≥0.165%；\n* 2.Secretory MM should have measurable markers, including:\n\n 1. specific M protein value (≥5g/L)；\n 2. and/or involved flc ≥100mg/L；\n 3. and/or measurable extramedullary foci (diameter\\>1cm on CT);\n* 3.Age≥18 years, male or female;\n* 4.ECOG 0-2 points, with life expectance ≥3 months; GA score \\<2;\n* 5.ALT/AST level \\<2.5 times of the maximum of normal range; total bilirubin\\<1.5 times of normal maximum；\n* 6.Neutrophil count≥1.5×109/L, platelet count≥50×109/L;\n* 7.eGFR≥40ml/min，except in the case of myeloma-related nephropathy;\n* 8.Normal left ventricular ejaculation rate, NYHA stage 1, pulmonary function GOLD stage 1;\n* 9.Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;\n* 10.Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.\n\nExclusion Criteria:\n\n* 1.With ≥2 degree of peripheral neuropath or with pain;\n* 2.Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;\n* 3.With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;\n* 4.Patients in pregnancy or lactation;\n* 5.Allergic constitution or being allergic to any drug within the regimen of the trial;\n* 6.With uncontrolled mental diseases;\n* 7.With active infection;\n* 8.With non-myeloma-associated acute renal dysfunction;\n* 9.With active hepatitis;\n* 10.HIV positive;\n* 11.History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;\n* 12.With other conditions that the investigators think unfit for the trial.'}, 'identificationModule': {'nctId': 'NCT04025450', 'briefTitle': 'Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients, a Phase I/II, Multiple Center, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SZ-ChiVRD VS VRD-MM02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chidamide plus VRD', 'description': 'Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14', 'interventionNames': ['Drug: Chidamide+VRD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VRD', 'description': 'Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14', 'interventionNames': ['Drug: VRD']}], 'interventions': [{'name': 'Chidamide+VRD', 'type': 'DRUG', 'description': 'Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14', 'armGroupLabels': ['Chidamide plus VRD']}, {'name': 'VRD', 'type': 'DRUG', 'description': 'Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14', 'armGroupLabels': ['VRD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fu chengcheng, Phd', 'role': 'CONTACT', 'email': 'fuchengcheng@suda.edu.cn', 'phone': '13962191404'}], 'facility': 'First Affiliated Hospital, Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Chengcheng Fu, PhD', 'role': 'CONTACT', 'email': 'fuzhengzheng@suda.edu.cn', 'phone': '13962191404'}], 'overallOfficials': [{'name': 'chengcheng Fu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Suzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}