Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT06342466
Status:
RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'C467566', 'term': 'pomalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'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': '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Bortezomib, pomalidomide, dexamethasone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-25', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hematologic VGPR + CR rate at 6 months', 'timeFrame': '6 months', 'description': 'Hematologic very good partial response plus complete response rate at 6 months'}], 'secondaryOutcomes': [{'measure': 'Overall Hematologic response rate at 6 months', 'timeFrame': '6 months', 'description': 'Overall Hematologic partial response, very good partial response rate and complete response at 6 months'}, {'measure': 'At least one organ response at 6 months', 'timeFrame': '6 months', 'description': 'At least one organ response (cardiac response, renal response, liver response) at 6 months'}, {'measure': 'TTNT at 2 years', 'timeFrame': '2 years', 'description': 'Time to next treatment at 2 years'}, {'measure': 'Estimated PFS at 2 years', 'timeFrame': '2 years', 'description': 'Estimated Progression free survival at 2 years'}, {'measure': 'Estimated OS at 2 years', 'timeFrame': '2 years', 'description': 'Estimated Overall Survival at 2 years'}, {'measure': 'TRAE', 'timeFrame': '6 months', 'description': 'Treatment-related adverse events up to 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.', 'detailedDescription': 'Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.\n2. Newly diagnosed or previous treated AL amyloidosis\n3. Patients must be ≥ 18 years of age.\n4. ECOG performance status 0, 1 or 2.\n5. Measurable disease defined by at least one of the following:\n\n ① serum free light chain (FLC) ≥2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg/dL (20 mg/L).\n\n ②. presence of a monoclonal spike that is ≥5 g/l.\n6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).\n7. Absolute neutrophil count (ANC) ≥1.0 X 10\\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\\^9/L\n8. eGFR ≥20 mL/min/ 1.73 m\\^2\n9. Written informed consent in accordance with local and institutional guidelines.\n10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.'}, 'identificationModule': {'nctId': 'NCT06342466', 'briefTitle': 'Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis', 'orgStudyIdInfo': {'id': '2023-358-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BPd', 'description': 'BPd regimen (Bortezomib, pomalidomide, and dexamethasone) will be applied every 28 days until progression of disease, unacceptable toxicity or subsequent therapy, for a maximum of six cycles.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Pomalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib 1.3mg/m2 sc weekly', 'armGroupLabels': ['BPd']}, {'name': 'Pomalidomide', 'type': 'DRUG', 'description': '4mg per day taken orally on 1-21 of repeated 28-day cycles', 'armGroupLabels': ['BPd']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone 20mg-40mg weekly', 'armGroupLabels': ['BPd']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Liu', 'role': 'CONTACT', 'email': 'pkuphliuyang@bjmu.edu.cn', 'phone': '+8613716926210'}, {'name': 'Jin Lu', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yang Liu, Dr', 'role': 'CONTACT', 'email': 'pkuphliuyang@vip.sina.com', 'phone': '86-13716926210'}], 'overallOfficials': [{'name': 'Jin Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jin Lu, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jin Lu, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}