THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

PHASE2CompletedINTERVENTIONAL
Enrollment

378

Participants

Timeline

Start Date

March 31, 2002

Primary Completion Date

October 31, 2007

Study Completion Date

January 31, 2009

Conditions
Multiple Myeloma
Interventions
DRUG

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"

DRUG

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)"

DRUG

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)"

DRUG

Cyclophosphamide

Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation

DRUG

Melphalan

Melphalan 200 mg/sqm on day -1 for first and second ASCT

All Listed Sponsors
lead

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

NCT01341262 - THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM) | Biotech Hunter | Biotech Hunter