Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00205751
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Response rate'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Time to response'}, {'measure': 'Toxicity'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'first line treatment', 'thalidomide', 'melphalan'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '20418244', 'type': 'DERIVED', 'citation': 'Ludwig H, Adam Z, Tothova E, Hajek R, Labar B, Egyed M, Spicka I, Gisslinger H, Drach J, Kuhn I, Hinke A, Zojer N. Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma. Haematologica. 2010 Sep;95(9):1548-54. doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.'}, {'pmid': '18955563', 'type': 'DERIVED', 'citation': 'Ludwig H, Hajek R, Tothova E, Drach J, Adam Z, Labar B, Egyed M, Spicka I, Gisslinger H, Greil R, Kuhn I, Zojer N, Hinke A. Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma. Blood. 2009 Apr 9;113(15):3435-42. doi: 10.1182/blood-2008-07-169565. Epub 2008 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease\n* WHO performance status 0,1,2,or 3\n* No prior treatment of multiple myeloma\n* Clear requirement of treatment (usually Durie/Salmon stage II or III)\n* Anticipated life expectancy of at least 3 months\n* Adequate organ function\n* Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study\n* Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal\n* Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent\n\nExclusion Criteria:\n\n* Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease\n* Benign monoclonal gammopathy\n* Multiple myeloma of IgM without osteolytic bone lesions\n* Smouldering myeloma\n* More than 3 irradiation fields\n* Irreversible performance status of WHO4\n* Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs\n* Women of childbearing potential\n* Preexisting peripheral polyneuropathy\n* Congestive heart failure NYHA III, IV\n* Acute infection requiring systemic antibiotics at study entry until resolved\n* Any uncontrolled underlying medical condition (eg diabetes, glaucoma)\n* Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years'}, 'identificationModule': {'nctId': 'NCT00205751', 'briefTitle': 'Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Austrian Forum Against Cancer'}, 'officialTitle': 'International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': '01-002-0601'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thalidomide/Dexamethasone vs Melphalan/Prednisone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1190', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital, 1st Medical Department-center for oncology and hematology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Heinz Ludwig, MD,Univ.Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilhelminenspital 1st medical dep.-center for oncology and hematology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austrian Forum Against Cancer', 'class': 'OTHER'}}}}