drugset / Trial / NCT00406978
Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2006-02
- Primary completion
- 2010-09
- Completion
- 2014-04
Publications
- Background Buzaid AC, Durie BG. Management of refractory myeloma: a review. J Clin Oncol. 1988 May;6(5):889-905. doi: 10.1200/JCO.1988.6.5.889.
- Background Palumbo A, Bertola A, Falco P, Rosato R, Cavallo F, Giaccone L, Bringhen S, Musto P, Pregno P, Caravita T, Ciccone G, Boccadoro M. Efficacy of low-dose thalidomide and dexamethasone as first salvage regimen in multiple myeloma. Hematol J. 2004;5(4):318-24. doi: 10.1038/sj.thj.6200403.
- Background Blade J, Samson D, Reece D, Apperley J, Bjorkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. doi: 10.1046/j.1365-2141.1998.00930.x. No abstract available.
- Background McKean-Cowdin R, Feigelson HS, Ross RK, Pike MC, Henderson BE. Declining cancer rates in the 1990s. J Clin Oncol. 2000 Jun;18(11):2258-68. doi: 10.1200/JCO.2000.18.11.2258.
- Background Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. doi: 10.1002/ajh.2830330203.
- Palumbo A, Larocca A, Genuardi M, Kotwica K, Gay F, Rossi D, Benevolo G, Magarotto V, Cavallo F, Bringhen S, Rus C, Masini L, Iacobelli M, Gaidano G, Mitsiades C, Anderson K, Boccadoro M, Richardson P; Italian Multiple Myeloma Network GIMEMA. Melphalan, prednisone, thalidomide and defibrotide in relapsed/refractory multiple myeloma: results of a multicenter phase I/II trial. Haematologica. 2010 Jul;95(7):1144-9. doi: 10.3324/haematol.2009.017913. Epub 2010 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Defibrotide | Oligonucleotide (other) | 1.2 g | Intravenous |
| Subject | Defibrotide | Oligonucleotide (other) | 1.6 g | Intravenous |
| Subject | Defibrotide | Oligonucleotide (other) | 3.2 g | Intravenous |
| Subject | Defibrotide | Oligonucleotide (other) | 4.8 g | Intravenous |
| Subject | Melphalan | Small molecule | 0.25 mg/kg | Oral |
| Subject | Prednisone | Other / unclassified | 1.5 mg/kg | Oral |
| Subject | Thalidomide | Other / unclassified | 100 mg | Oral |