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Sponsored by: |
Gruppo Italiano per lo Studio del Mieloma Multiplo |
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Information provided by: | Gruppo Italiano per lo Studio del Mieloma Multiplo |
ClinicalTrials.gov Identifier: | NCT00232934 |
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Thalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 400 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | May 2010 |
Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years.
Advances 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%.
Due 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista | |
Torino, Italy, 10126 | |
Cattedra e Divisione di Ematologia Università TOR Vergata Ospedale S.Eugenio | |
Roma, Italy, 00100 | |
U.O. di Ematologia e Trapianto di Cellule Staminali, IRCCS Casa Sollievo della Sofferenza | |
Foggia, Italy, 71013 | |
Clinica Medica I, Policlinico Monteluce | |
Perugia, Italy, 06123 | |
Divisione di Ematologia Ospedali Riuniti | |
Reggio Calabria, Italy, 89100 | |
Divisione di Ematologia e Trapianto di Midollo Osseo- Ospedale Cervello | |
Palermo, Italy, 90146 | |
Istituto di Ematologia - Università Cattolica | |
Roma, Italy, 00168 | |
Ematologia - H.S. Gerardo | |
Monza, Italy, 20052 | |
Divisionedi Ematologia - Ospedali Riuniti | |
Bergamo, Italy, 24127 | |
Cattedra e Divisione di Ematologia Università Federico II | |
Napoli, Italy, 80131 | |
Istituto di Ematologia e Oncologia Medica "Seragnoli"- Università di Bologna | |
Bologna, Italy, 40138 | |
Dipartimento di Biotecnologie ed Ematologia - Università La Sapienza | |
Roma, Italy, 00161 | |
Divisione di Ematologia - Az. Osp. S.Croce Carle | |
Cuneo, Italy, 26100 |
Principal Investigator: | Mario Boccadoro, MD | Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy |
Study Director: | Antonio Palumbo, MD | Divisione di Ematologia dell'Università degli Studi di Torino, Azienda Ospedaliera S.Giovanni Battista, Torino, Italy |
Study ID Numbers: | GISMM2001-A |
Study First Received: | October 4, 2005 |
Last Updated: | October 4, 2005 |
ClinicalTrials.gov Identifier: | NCT00232934 |
Health Authority: | Italy: Ministry of Health |
Myeloma Thalidomide Diagnosis Elderly patients |
Melphalan Prednisone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Immunosuppressive Agents Glucocorticoids Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Leprostatic Agents |