Study: NCT01134484

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone
Description: * INDUCTION THERAPY~  1. VTD ARM: 40 mg/d days 1-2, 4-5, 8-9 and 11-12 (3 cycles, 21 days each)~ 2. TD ARM: 40 mg/d days 1-4 and 9-12 (3 cycles, 21 days each)~* AFTER PBSC COLLECTION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide)~* AFTER FIRST TRANSPLANTATION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) and repeated every 28 days, for 3 months~* REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation)~  1. VTD ARM: 40 mg/d days 1-2, 8-9, 15-16 and 22-23 (2 cycles, 35 days each)~ 2. TD ARM: 40 mg/d days 14 and 20-23 (2 cycles, 35 days each)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: * INDUCTION THERAPY~  1. VTD ARM: 40 mg/d days 1-2, 4-5, 8-9 and 11-12 (3 cycles, 21 days each)~ 2. TD ARM: 40 mg/d days 1-4 and 9-12 (3 cycles, 21 days each)~* AFTER PBSC COLLECTION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide)~* AFTER FIRST TRANSPLANTATION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) and repeated every 28 days, for 3 months~* REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation)~  1. VTD ARM: 40 mg/d days 1-2, 8-9, 15-16 and 22-23 (2 cycles, 35 days each)~ 2. TD ARM: 40 mg/d days 14 and 20-23 (2 cycles, 35 days each)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Peripheral Blood Stem Cell (PBSC) collection
Description: * Cyclophosphamide (CTX): 4 g/sqm given in a single day (day 0)~* G-CSF: 10 µcg/kg/d, starting on day +2 from CTX and continuing until completion of PBSC collection

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Peripheral Blood Stem Cell (PBSC) collection
Description: * Cyclophosphamide (CTX): 4 g/sqm given in a single day (day 0)~* G-CSF: 10 µcg/kg/d, starting on day +2 from CTX and continuing until completion of PBSC collection

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: First Autologous Transplantation
Description: * HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)~* G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: First Autologous Transplantation
Description: * HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)~* G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Second Autologous Transplantation
Description: * HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)~* G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Second Autologous Transplantation
Description: * HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)~* G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10\^9/L for 3 consecutive days