Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT00988312
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2009-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010954', 'term': 'Plasmacytoma'}], '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific T-cell proliferation/cytokine secretion'}], 'secondaryOutcomes': [{'measure': 'number of T cells', 'timeFrame': 'pre and post vaccination'}, {'measure': 'monoclonal protein', 'timeFrame': 'pre and post vaccination'}, {'measure': 'plasmacells in bone marrow', 'timeFrame': 'pre and post vaccination'}, {'measure': 'vital signs', 'timeFrame': 'pre and post vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dendritic cells (DC)', 'idiotype (Id)', 'immunotherapy'], 'conditions': ['Multiple Myeloma', 'Plasmocytoma']}, 'descriptionModule': {'briefSummary': 'Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* multiple myeloma\n* stage I (Salmon \\& Durie)\n* no cytoreductive pre-treatment\n\nExclusion Criteria:\n\n* myeloma stages II-III\n* asecretory disease'}, 'identificationModule': {'nctId': 'NCT00988312', 'briefTitle': 'Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Carl Gustav Carus'}, 'officialTitle': 'Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'MyelomVak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 's.c. vaccination', 'description': 'vaccine given subcutaneously', 'interventionNames': ['Biological: autologous idiotype-protein pulsed dendritic cells']}, {'type': 'EXPERIMENTAL', 'label': 'i.v. vaccination', 'description': 'vaccines are given intravenously', 'interventionNames': ['Biological: autologous idiotype-protein pulsed dendritic cells']}], 'interventions': [{'name': 'autologous idiotype-protein pulsed dendritic cells', 'type': 'BIOLOGICAL', 'description': 'Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks', 'armGroupLabels': ['i.v. vaccination', 's.c. vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'University Hospital Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Susanne Gretzinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Carl Gustav Carus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Susanne Gretzinger', 'oldOrganization': 'University Hospital Carl Gustav Carus'}}}}