Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT00232934
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2005-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2005-10-04', 'studyFirstSubmitQcDate': '2005-10-04', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate'}, {'measure': 'Progression Free Survival'}, {'measure': 'Event Free Survival'}], 'secondaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Overall Survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myeloma', 'Thalidomide', 'Diagnosis', 'Elderly patients'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '10091392', 'type': 'BACKGROUND', 'citation': 'San Miguel JF, Blade Creixenti J, Garcia-Sanz R. Treatment of multiple myeloma. Haematologica. 1999 Jan;84(1):36-58.'}, {'pmid': '10564685', 'type': 'BACKGROUND', 'citation': 'Singhal S, Mehta J, Desikan R, Ayers D, Roberson P, Eddlemon P, Munshi N, Anaissie E, Wilson C, Dhodapkar M, Zeddis J, Barlogie B. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med. 1999 Nov 18;341(21):1565-71. doi: 10.1056/NEJM199911183412102.'}, {'pmid': '11049970', 'type': 'BACKGROUND', 'citation': 'Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, Treon SP, Lin B, Schlossman RL, Richardson P, Muller G, Stirling DI, Anderson KC. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood. 2000 Nov 1;96(9):2943-50.'}, {'pmid': '21228328', 'type': 'DERIVED', 'citation': 'Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omede P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A. Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients. Blood. 2011 Mar 17;117(11):3025-31. doi: 10.1182/blood-2010-09-307645. Epub 2011 Jan 12.'}, {'pmid': '18505783', 'type': 'DERIVED', 'citation': 'Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. doi: 10.1182/blood-2008-04-149427. Epub 2008 May 27.'}, {'pmid': '16530576', 'type': 'DERIVED', 'citation': 'Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. doi: 10.1016/S0140-6736(06)68338-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.', 'detailedDescription': 'Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years.\n\nAdvances in systemic and supportive therapy increased remission rates and overall survival, but multiple myeloma still remains an incurable haematological malignancy. Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%.\n\nDue to its activity, Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* untreated myeloma patients\n* age \\>65 years of age or younger but excluded from transplant procedure\n* Durie \\& Salmon stage II or III myeloma and measurable disease.\n* Patients agreed to use contraception\n\nExclusion Criteria:\n\n* other cancer\n* psychiatric disease and any grade 2 peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT00232934', 'briefTitle': 'Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano per lo Studio del Mieloma Multiplo'}, 'officialTitle': 'Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.', 'orgStudyIdInfo': {'id': 'GISMM2001-A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thalidomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Divisionedi Ematologia - Ospedali Riuniti', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '26100', 'city': 'Cuneo', 'country': 'Italy', 'facility': 'Divisione di Ematologia - Az. Osp. S.Croce Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '71013', 'city': 'Foggia', 'country': 'Italy', 'facility': 'U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'Ematologia - H.S. Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Cattedra e Divisione di Ematologia Università Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '06123', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Clinica Medica I, Policlinico Monteluce', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '89100', 'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Divisione di Ematologia Ospedali Riuniti', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '00100', 'city': 'Roma', 'country': 'Italy', 'facility': 'Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Istituto di Ematologia - Università Cattolica', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': "Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Mario Boccadoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy"}, {'name': 'Antonio Palumbo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano per lo Studio del Mieloma Multiplo', 'class': 'OTHER'}}}}