Pethema Multiple Myeloma 2000

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 31, 2000

Study Completion Date

February 28, 2005

Conditions
Multiple Myeloma
Interventions
DRUG

Alternating chemotherapy

"4 cycles of alternating chemotherapy VBMCP/VBAD (every 5 weeks). VBMCP: Vcr 2 mg ev day 1, BCNU 0.5 mg/kg ev day 1, Cyclophosphamide 10 mg/kg day 1, Melphalan 0.25 mg/kg v.o. days 1-4, Prednisone 1 mg/kg v.o. days 1-4, 0.5 mg/kg days 5-8 and 0.25 mg/kg days 9-12.~VBAD: Vcr 1 mg e.v. day 1, BCNU 30 mg/m 2 e.v. day 1, Adriamycine 40 mg/m 2 day 1, Dexamethasone 40 mg/m 2 days 1-4, 9-12 and 17-20."

PROCEDURE

Autologous Transplantation

"Autologous Transplantation :~BUMEL:Busulfan, total dose 12 mg/kg (days -6 a -3; prophylaxis with difenilhidantoine) Melphalan 140 mg/m 2 , ev day -2 TASPE: To investigator criteria"

DRUG

Maintenance

"At 3 months of transplantation or with \>1.500 neutrophiles/ \> 75.000 platelets mm 3 .~Prednisone: 50 mg alternating days during 2 years Interferon alfa 2-b: 3 M UI s.c. Three times a week until relapse."

PROCEDURE

Second transplantation

In cases that no reach CR with BUMEL is programmed second transplantation, after 4-8 months .

PROCEDURE

ALOGENIC MINI TRASPLANTATION

ALOGENIC MINI TRASPLANTATION Fludarabine 30 mg / m 2 / day, days -7, -6, -5, -4, -3 Melphalan 70 mg / m 2 / day, day -2 Prophylaxis EICH: CsA + MTX or CsA + MOFETIL

All Listed Sponsors
lead

PETHEMA Foundation

OTHER

NCT00560053 - Pethema Multiple Myeloma 2000 | Biotech Hunter | Biotech Hunter