Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 8:50 AM
Study NCT ID:
NCT01274403
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2010-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With 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': 'D008558', 'term': 'Melphalan'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D013792', 'term': 'Thalidomide'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2010-12-28', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy', 'timeFrame': 'from 8 to 12 months', 'description': 'To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment'}, {'measure': 'To assess the toxicity', 'timeFrame': 'From 1 to 12 months', 'description': 'To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0'}], 'secondaryOutcomes': [{'measure': 'To evaluate the Overall Survival (OS) in the 2 arms of treatment', 'timeFrame': 'From 1 to 60 months', 'description': 'OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause'}, {'measure': 'To evaluate the Duration of Remission (DR) in the 2 arms of treatment', 'timeFrame': 'From 8 to 60 months', 'description': 'DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Elderly patients'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed of multiple myeloma.\n* Age \\> 65 years\n* ECOG \\<= 3\n* Written informed consent given at the time of randomization\n* Patients with age \\<= 65 but not eligible for high dose treatment with stem cells support\n\nExclusion Criteria:\n\n* ECOG \\> 3\n* current neoplasm..\n* contraindications to use thalidomide\n* peripheral neurophaty'}, 'identificationModule': {'nctId': 'NCT01274403', 'briefTitle': 'A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Studio Linfomi'}, 'orgStudyIdInfo': {'id': 'MM03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melphalan, prednisone plus Thalidomide', 'interventionNames': ['Drug: Melphalan, Prednisone and Thalidomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Melphalan and Prednisone', 'interventionNames': ['Drug: Melphalan, Prednisone and Thalidomide']}], 'interventions': [{'name': 'Melphalan, Prednisone and Thalidomide', 'type': 'DRUG', 'armGroupLabels': ['Melphalan and Prednisone', 'Melphalan, prednisone plus Thalidomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41120', 'city': 'Modena', 'state': 'Modena', 'country': 'Italy', 'facility': 'Gruppo Italiano Studio Linfoma', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Linfomi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gruppo Italiano Studio Linfoma', 'oldOrganization': 'GISL'}}}}