24
Participants
Start Date
February 28, 2006
Primary Completion Date
September 30, 2010
Study Completion Date
April 30, 2014
Prednisone
Prednisone will be given orally at the dose of 1.5 mg/Kg for 4 days followed by a 31-day rest period (days 5 through 35)
Melphalan
Melphalan will be given orally at the dose of 0.25 mg/Kg for 4 days,
Thalidomide
Thalidomide will be administered orally at the initial dose of 50 mg/day p.o. once daily, with increment of 50 mg after a month to acceptable tolerance (maximum 100 mg), continuously for the entire 6 courses.
Defibrotide
Lev - 1 Def = 10 mg/Kg (max 0.6 g) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Lev - 1 Def = 1.2 g p.o (400 mg every 8 hours) on days 1-4, followed by 1.2 g (400 mg every 8 hours) p.o. through day 35 Level + 1 Def = 17 mg/Kg (max 1.2 g) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 1 Def = 2.4 g p.o. (400 mg every 4 hours) on days 1-4, followed by 1.6 g p.o. (400 mg every 6 hours) through day 35 Lev + 2 Def = 34 mg/Kg (max 2.4 g) as a i.v. injection on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 2 Def = 4.8 g p.o. (800 mg every 4 hours) on days 1-4, followed by 3.2 g p.o. (800 mg every 6 hours) through day 35 Lev + 3 Def = 51mg/Kg (max 3.6 g) as a i.v. injection on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) through day 35 Lev + 3 Def = 7.2 g p.o.(1200 mg every 4 hours ) on days 1-4, followed by 4.8 g p.o. (1200 mg every 6 hours) given p.o. through day 35
Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista, Torino
Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia, Novara
Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova, Reggio Emilia
Policlinico Monteluce, Clinica Medica I, Perugia
Divisione Di Ematologia, Ospedali Riuniti, Reggio Calabria
Silvio Aime
OTHER