Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT01296503
Status:
COMPLETED
Last Update Posted:
2011-02-15
First Post:
2011-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide Plus Dexamethasone as Maintenance Therapy for 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': 'D013792', 'term': 'Thalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-14', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-02-14', 'lastUpdatePostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free survival', 'timeFrame': '36 months', 'description': 'Primary endpoint: progression free survival (PFS) PFS was defined as the time between randomization and any documentation of relapse, progression, or death by any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '36 months', 'description': 'Secondary endpoints: overall survival (OS) was defined as the interval from randomization to death (or the last follow-up for surviving patients). For patients who were not randomized, OS was calculated from the date of diagnosis until the date of death or last follow-up.'}, {'measure': 'safety of thalidomide', 'timeFrame': '36 months', 'description': 'The number of patients experiencing adverse events grade 3 or 4 were compared between treatment arms. Adverse events were classified as defined by the National Cancer Institute Common Toxicity Criteria, version 2. Safety evaluations were focused especially on neurological symptoms and the development of deep venous thrombosis (DVT). Adverse events evaluations were performed at the time of response assessment and whenever a new clinical manifestation suggestive of toxicity appeared.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Treatment', 'Maintenance', 'Thalidomide'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.', 'detailedDescription': 'Patients were recruited prior to receiving induction therapy, and randomization in a 1:1 ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted of the following four phases:\n\n1. induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every 21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily for 4 days;\n2. cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell mobilization;\n3. melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);\n4. Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg daily by mouth) for 12 months or until disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;\n* age 18-70 years;\n* Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;\n* normal hepatic function, defined as serum bilirubin \\<3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) \\<4x normal.\n\nExclusion Criteria:\n\n* evidence of disease progression after ASCT;\n* cardiac dysfunction (systolic ejection fraction \\<50%);\n* chronic respiratory disease (carbon monoxide diffusion \\<50% of normal).'}, 'identificationModule': {'nctId': 'NCT01296503', 'briefTitle': 'Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma', 'organization': {'class': 'NETWORK', 'fullName': 'Grupo de Estudos Multicentricos em Onco-Hematologia'}, 'officialTitle': 'Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial', 'orgStudyIdInfo': {'id': 'GBRAM0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone (Arm A)', 'description': 'Sixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Thalidomide and Dexamethasone (Arm B)', 'description': 'D+60 after ASCT: dexamethasone plus thalidomide 200 mg by mouth daily for 12 months or until disease progression.\n\nThe dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.', 'interventionNames': ['Drug: Thalidomide plus dexamethasone']}], 'interventions': [{'name': 'Thalidomide plus dexamethasone', 'type': 'DRUG', 'otherNames': ['Thalomid', 'Baycadron', 'DexPak', 'Decadron'], 'description': 'D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.\n\nThe dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.', 'armGroupLabels': ['Thalidomide and Dexamethasone (Arm B)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Baycadron', 'DexPak', 'Decadron'], 'description': 'dexamethasone alone 40 mg/day for 4 days every 28 days', 'armGroupLabels': ['Dexamethasone (Arm A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21941913', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Clementino Fraga Filho', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Estadual de Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade de São Paulo- Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa de Misericórdia de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Angelo Maiolino, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Estudos Multicentricos em Onco-Hematologia', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Angelo Maiolino, MD, PhD', 'oldOrganization': 'Universidade Federal do Rio de Janeiro'}}}}