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Sponsored by: |
University of Turin, Italy |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00358020 |
The purpose of this study is to evaluate the safety and the efficacy of the association of Melphalan/Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MP regimen.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: THALIDOMIDE Drug: BORTEZOMIB |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2008 |
In Multiple Myeloma (MM) patients, the conventional treatment is the oral combination melphalan and prednisone (MP). thalidomide has been widely used in myeloma, it has been proved clinical effective in refractory myeloma patients, it acts sinergistically in association with dexamethasone. In newly diagnosed patients, the combination oral MP plus thalidomide increased the partial and complete response rate.Bortezomib represents a novel class of anti-cancer drugs, it is active in patient with multiple myeloma who are refractory to conventional chemotherapy. In a preliminary report, the combination of VELCADE and Thalidomide induced a remarkable 60% PR rate in advanced refractory myeloma patients. This study will evaluate the safety and the efficacy of the association of Melphalan/ Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory myeloma patients.
This association might further increase the response rate achieved by the standard oral MP regimen.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient is of a legally consenting age as defined by local regulations.
Exclusion Criteria:
Patient has an absolute neutrophil count <0.75 × 109/L within 14 days before enrollment.
Italy | |
Divisione Di Ematologia, Ospedale Centrale | |
BOLZANO, Italy | |
UNITÀ Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell’Annunziata, Azienda Ospedaliera Di Cosenza | |
COSENZA, Italy | |
Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello | |
PALERMO, Italy | |
Ematologia, Azienda Ospedaliera S.Giovanni Battista | |
TORINO, Italy, 10126 | |
Cattedra E Divisione Di Ematologia, UNIVERSITÀ Tor Vergata, Ospedale S.Eugenio | |
ROMA, Italy | |
Divisione Universitaria Ematologia - Az.Osp. San Giovanni Battista | |
TORINO, Italy, 10126 | |
Divisione Di Ematologia, Ospedali Riuniti | |
REGGIO CALABRIA, Italy |
Principal Investigator: | MARIO BOCCADORO, MD | DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY |
Study Director: | ANTONIO PALUMBO, MD | DIVISONE DI MEATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY |
Study ID Numbers: | X05141, MPTV |
Study First Received: | July 27, 2006 |
Last Updated: | November 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00358020 History of Changes |
Health Authority: | Italy: Ministry of Health |
MYELOMA, THALIDOMIDE, BORTEZOMIB |
Melphalan Prednisone Immunoproliferative Disorders Immunologic Factors Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases |
Paraproteinemias Hemostatic Disorders Angiogenesis Inhibitors Immunosuppressive Agents Protease Inhibitors Multiple Myeloma Anti-Bacterial Agents Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Anti-Bacterial Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances Bortezomib Vascular Diseases Enzyme Inhibitors Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Lymphoproliferative Disorders |