378
Participants
Start Date
March 31, 2002
Primary Completion Date
October 31, 2007
Study Completion Date
January 31, 2009
Thalidomide
"* INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-120 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)~* AFTER PBSC COLLECTION: 200 mg/d from day after last PBSC collection until the day before first course of MEL-200~* AFTER FIRST TRANSPLANTATION: 200 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200"
Dexamethasone
"* INDUCTION THERAPY: 40 mg/d days 1-4, 9-12 and 17-20 (cycles 1 and 3, 30 days each); 40 mg/d days 1-4 (cycles 2 and 4, 30 days each)~* AFTER PBSC COLLECTION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide)~* AFTER FIRST TRANSPLANTATION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)"
Zoledronic acid
"* INDUCTION THERAPY: 4 mg i.v. once a cycle for 4 cycles (30 days each)~* AFTER PBSC COLLECTION: 4 mg i.v. once (the same day of resumption of Thalidomide)~* AFTER FIRST TRANSPLANTATION: 4 mg i.v. once a cycle (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)"
Cyclophosphamide
Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation
Melphalan
Melphalan 200 mg/sqm on day -1 for first and second ASCT
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER