Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00216151
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage 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': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study terminated due to low patient enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '· To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': '· To examine the effect of intravenous zoledronic acid at the above schedule on percent change in bone mineral density of the total hip and femur.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Bisphosphonates'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://hoosieroncologygroup.org/', 'label': 'Hoosier Oncology Group Home Page'}]}, 'descriptionModule': {'briefSummary': 'Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates.\n\nThis trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma', 'detailedDescription': 'OUTLINE: This is a multi-center study.\n\n* Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed.\n\nPerformance status: ECOG performance status 0-3 (KPS 30 - 100)\n\nLife expectancy: 12 months\n\nHematopoietic:\n\n* Hb \\>10 g/dl within 14 days prior to registration\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Serum creatinine \\< 2 mg/dl within 14 days prior to registration\n\nCardiovascular:\n\n* Not specified\n\nPulmonary:\n\n* Not specified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:\n* Presence of bone marrow clonal plasma cells (more than 10%)\n* Presence of an M-protein in serum and/or urine (no concentration specified)\n* Serum calcium \\< 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey\n* No symptoms of hyperviscosity, amyloidosis or recurrent infection\n* Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration\n* Negative pregnancy test\n\nExclusion Criteria:\n\n* No previous treatment with bisphosphonates\n* No disorders of the parathyroid or thyroid glands\n* No current breastfeeding\n* No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason \\< grade 7 prostate cancers'}, 'identificationModule': {'nctId': 'NCT00216151', 'briefTitle': 'Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Hoosier Cancer Research Network'}, 'officialTitle': 'A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35', 'orgStudyIdInfo': {'id': 'HOG MM02-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.', 'interventionNames': ['Drug: Zoledronic Acid']}, {'type': 'NO_INTERVENTION', 'label': 'B', 'description': 'Patients will be randomly assigned by study number to observation only.'}], 'interventions': [{'name': 'Zoledronic Acid', 'type': 'DRUG', 'description': 'Zoledronic Acid 4mg, every three months', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46515', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'Elkhart Clinic', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Oncology Hematology Associates of SW Indiana', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Quality Cancer Center (MCGOP)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47904', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arnett Cancer Care', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northern Indiana Cancer Research Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Providence Medical Group', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '47804', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'AP&S Clinic', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}], 'overallOfficials': [{'name': 'Attaya Suvannasankha, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoosier Oncology Group, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoosier Cancer Research Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Walther Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Attaya Suvannasankha, M.D.', 'oldOrganization': 'Hoosier Oncology Group'}}}}