Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT01272466
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '15 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'vaccination', 'antiapoptotic proteins', 'proteasome inhibition'], 'conditions': ['Relapsed Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of multiple myeloma\n* tissue type of HLA-A1, HLA-A2 or HLA-A3\n* Performance status \\< 2\n* Adequate bone marrow - renal and liver function\n* written informed concent\n\nExclusion Criteria:\n\n* candidate for bone marrow transplantation\n* other malignancies than multiple myeloma\n* other significant medical disease (heart-, lung or liver disease or diabetes)\n* allergy\n* active autoimmune disease\n* treatment with immunosuppressive drugs\n* treatment with other experimental drugs\n* uncontrolled hypercalcemia'}, 'identificationModule': {'nctId': 'NCT01272466', 'briefTitle': 'Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma', 'orgStudyIdInfo': {'id': '2006-003619-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'peptides from antiapoptotic proteins', 'interventionNames': ['Biological: peptides derived from antiapoptotic proteins']}], 'interventions': [{'name': 'peptides derived from antiapoptotic proteins', 'type': 'BIOLOGICAL', 'description': '8 Vaccinations on day 2 and 9 in every bortezomib treatment series', 'armGroupLabels': ['peptides from antiapoptotic proteins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Haematology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Lene M Knudsen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Haematology, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Lene Meldgaard Knudsen', 'investigatorAffiliation': 'Herlev Hospital'}}}}