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Sponsored by: |
University of Turin, Italy |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00406978 |
This study will evaluate the safety and the efficacy of the association of Melphalan/ Prednisone/Thalidomide/Defibrotide (MPTD) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by oral MPT regimen
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Thalidomide Drug: Defibrotide Drug: Alkeran Drug: Prednisone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Multi-Center, Open Label Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients |
Estimated Enrollment: | 75 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | October 2006 |
Defibrotide (DF) is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects, which has been shown to be active in various microangiopathies, including the treatment and prophylaxis of veno-occlusive disease. While DF has minimal inhibitory effect on multiple myeloma (MM) in cell isolates, it showed single agent activity on human MM xenografts in SCID/NOD mice and markedly increased responsiveness of MM to cytotoxic agents, including melphalan, cyclophosphamide and dexamethasone in the same models. DF might thus enhance the response rate of Melphalan, Prednisone and Thalidomide, while protecting against the prothrombotic state seen with this combination in the treatment of MM. In this multicenter, open label, non-randomised phase I/II trial, dosing safety and efficacy of melphalan, prednisone, thalidomide, and DF (MPTD) were determined in pts with relapsed/refractory MM.
Primary refractory or pts receiving therapeutic anticoagulation were excluded. Oral melphalan was administered at 0,25 mg/Kg on D1-4, oral prednisone at 1,5 mg/kg on D 1-4, thalidomide was delivered at 50 mg on D1-35 on cycle 1 and at 100 mg from cycle 2 to cycle 6.
Level + 1 DF = 17 mg/Kg i.v. or 2.4 g p.o. D1-4, followed by 1.6 g p.o. through D 35 Level + 2 DF = 34 mg/Kg i.v. or 4.8 g p.o. D 1-4, followed by 3.2 g p.o. through D 35 Level + 3 DF = 51 mg/Kg i.v. or 7.2 g p.o. D 1-4, followed by 4.8 g p.o. through D 35.
Each course was repeated every 35d for a total of 6 courses and no DVT prophylaxis was used.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
Contact: ANTONIO PALUMBO, MD | 011 6336107 ext +39 | gismm2001@yahoo.com |
Italy | |
Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia | Recruiting |
Novara, Italy, 28100 | |
Contact: Gianluca Gaidano, MD | |
Contact: Davide Rossi, MD rossidav@med.unipmn.it | |
Principal Investigator: Gianluca Gaidano, MD | |
Policlinico Monteluce, Clinica Medica I | Recruiting |
Perugia, Italy, 06123 | |
Contact: Anna Marina Liberati, MD 075/5783631 marinal@unipg.it | |
Principal Investigator: Anna Marina Liberati, MD | |
Divisione Di Ematologia, Ospedali Riuniti | Recruiting |
REGGIO CALABRIA, Italy | |
Contact: VINCENZO CALLEA, MD 0965/397222 calleamd@tin.it | |
Principal Investigator: VINCENZO CALLEA, MD | |
Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Luigi Gugliotta, MD gugliotta.luigi@asmn.re.it | |
Contact: Luciano Masini, MD masini.luciano@asmn.re.it | |
Principal Investigator: Luigi Gugliotta, MD | |
Italy, to | |
Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista | Recruiting |
TORINO, to, Italy, 10126 | |
Contact: Mario Boccadoro, MD 011 6336107 gismm2001@yahoo.com | |
Contact: Antonio Palumbo, MD | |
Principal Investigator: MARIO BOCCADORO, MD |
Principal Investigator: | MARIO BOCCADORO, MD | DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY |
Study ID Numbers: | MM2005 |
Study First Received: | November 30, 2006 |
Last Updated: | November 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00406978 |
Health Authority: | Italy: Ministry of Health |
MYELOMA THALIDOMIDE DEFIBRODITE |
Melphalan Prednisone Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases |
Defibrotide 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 Hematologic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Fibrinolytic Agents Hormones Anti-Bacterial Agents Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases |
Angiogenesis Modulating Agents Growth Inhibitors Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Cardiovascular Agents Glucocorticoids Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Platelet Aggregation Inhibitors Leprostatic Agents |