10
Participants
Start Date
September 30, 2003
Primary Completion Date
May 31, 2010
Study Completion Date
May 31, 2010
Dexamethasone
Dexamthasone 40mg every day, days -5 to -1 only will be given.
Cyclophosphamide
A dose of 60mg/kg (using calculated body weight - see appendix A.) will be infused on day-3, and -2. Cyclophosphamide is administered by intravenous infusion over 2-4 hrs in 250 mLs of Normal Saline (0.9%) or D5W Standard MESNA (60% or 36mg/kg) protection to prevent hemorrhagic cystitis will be given on day -3, -2 and -1.
Melphalan
Melphalan will be given as a single dose of 140mg/m2 on day -1. Subject weighing more than 60kg will be dosed according to their calculated body weight.Melphalan will be diluted in normal saline(0.9%NaCl) to a concentration of 1.5mg/ml. A dose of 140mg/m2 will be administered intravenously over a period \<or= 20 minutes on day -1.
Fludarabine
dose of 1.0mg/m2 on days -8,-5,-2.
Bortezomide
A dose of 1.0mg/m2 will be given as a bolus dose on day-8, day-5 and day-2 as per standard practice
Leukapheresis
On day 0 to collect donor cells for NK cell isolation
Interleukin
2 at 3x10x6 IU on days +1 to 13.
Infusion #1
Infusion of donor NK Cells #1 on day 0
Leukapheresis #2
on day +2
Infusion #2
on day +2
Auto Graft
on day +14
University of Arkansas for Medical Sciences/MIRT, Little Rock
University of Arkansas
OTHER