Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT00315757
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2006-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507357', 'term': 'mapatumumab'}, {'id': 'D000069286', 'term': 'Bortezomib'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2011-03-30', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2006-04-17', 'dispFirstSubmitQcDate': '2011-04-11', 'studyFirstSubmitQcDate': '2006-04-17', 'dispFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone', 'timeFrame': '17 cycles (up to a year)'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety, including the frequency and severity of adverse events and laboratory abnormalities, of mapatumumab in combination with bortezomib and bortezomib alone throughout the study period', 'timeFrame': '17 cycles (up to a year)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or refractory multiple myeloma (MM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with multiple myeloma that is refractory or has relapsed after treatment\n* Measurable serum and/or urine M-protein\n* Failed 1 or 2 prior therapies for multiple myeloma\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Received more than 2 prior therapies for multiple myeloma.\n* Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks\n* Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)\n* Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks\n* Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks\n* Subjects who received a stem cell transplant using cells from another individual\n* Previously treated with bortezomib or mapatumumab\n* Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection\n* Infection requiring antibiotics or hospitalization within the last 2 weeks\n* Major surgery within the last 4 weeks\n* Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)\n* History of other cancers within the past 5 years\n* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT00315757', 'briefTitle': 'Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Genome Sciences Inc.'}, 'officialTitle': 'A Phase 2, Multi-Center, Open-Label, Randomized Study of Mapatumumab (TRM-1 [HGS1012], a Fully Human Monoclonal Antibody to TRAIL-R1) in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'HGS1012-C1055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Bortezomib', 'interventionNames': ['Drug: Bortezomib']}, {'type': 'EXPERIMENTAL', 'label': 'B-10', 'description': 'Bortezomib and Mapatumumab 10 mg/kg', 'interventionNames': ['Biological: Mapatumumab', 'Drug: Bortezomib']}, {'type': 'EXPERIMENTAL', 'label': 'B-20', 'description': 'Bortezomib and Mapatumumab 20 mg/kg', 'interventionNames': ['Biological: Mapatumumab', 'Drug: Bortezomib']}], 'interventions': [{'name': 'Mapatumumab', 'type': 'BIOLOGICAL', 'description': '10 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.', 'armGroupLabels': ['B-10']}, {'name': 'Mapatumumab', 'type': 'BIOLOGICAL', 'description': '20 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.', 'armGroupLabels': ['B-20']}, {'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': '1.3 mg/m\\^2 IV (in the vein), twice weekly for two weeks (Days 1, 4, 8, and 11) of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.', 'armGroupLabels': ['A', 'B-10', 'B-20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic Medical Group, Inc.', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '34461', 'city': 'Lecanto', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer and Blood Disorders Center', 'geoPoint': {'lat': 28.85165, 'lon': -82.4876}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Capitol Comprehensive Cancer Care Clinic', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Methodist Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Department of Haematology, Royal North Shore Hospital', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Institute of Medical & Veterinary Science', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3181', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Haematology & BMT, Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Health Research Institute - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Notre Dame Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '570 017', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Bharath Hospital & Institute of Oncology', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '560027', 'city': 'Bangalore', 'country': 'India', 'facility': 'Bangalore Institute of Oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '110 029', 'city': 'New Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110 085', 'city': 'New Delhi', 'country': 'India', 'facility': 'Rajiv Gandhi Cancer Institute & Research Center', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Genome Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}