231
Participants
Start Date
August 31, 2002
Primary Completion Date
October 31, 2015
Study Completion Date
October 31, 2015
VAD
3 Cycles (3rd cycle optional): Vincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20
High-Dose cyclophosphamide
"Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1"
Hemopoietic stem cell procurement
Collection target = 10 x 10\^6 cells/kg
EDAP
Approximately 5-6 weeks after high-dose cyclophosphamide Etoposide 100 mg/m2/d d 1 - 4 CI Cisplatin 25 mg/m2/d d 1 - 4 CI Ara C l g/m2 d 5 Dexamethasone 40 mg d 1-5
Autologous Hemopoietic Stem Cell Transplant 1
4-6 weeks after EDAP: Melphalan 100 mg/m2 days -1 and -2
Autologous Hemopoietic Stem Cell Transplant 2
4-6 months after Transplant 1: Melphalan 100 mg/m2 days -1 and -2
Maintenance
3 months after Transplant 2: Intron A 3 X 10\^6 units /m2 M-W-F subcutaneously until relapse
University of Arkansas for Medical Sciences/MIRT, Little Rock
University of Arkansas
OTHER