Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

September 30, 2010

Study Completion Date

April 30, 2014

Conditions
Multiple Myeloma
Interventions
DRUG

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)

DRUG

Melphalan

Melphalan will be given orally at the dose of 0.25 mg/Kg for 4 days,

DRUG

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.

DRUG

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

Trial Locations (5)

10126

Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista, Torino

28100

Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia, Novara

42100

Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova, Reggio Emilia

06123

Policlinico Monteluce, Clinica Medica I, Perugia

Unknown

Divisione Di Ematologia, Ospedali Riuniti, Reggio Calabria

All Listed Sponsors
lead

Silvio Aime

OTHER

NCT00406978 - Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients | Biotech Hunter | Biotech Hunter