38
Participants
Start Date
June 30, 2007
Primary Completion Date
October 31, 2011
Study Completion Date
September 30, 2012
Palifermin
Palifermin 60 mcg/kg/d of the actual body weight unless actual body weight is \>40% of the Ideal body weight (IBW), then adjusted body weight (AdBW) will be used for dose calculations - administered on Day - 5,-4, - 3 and then repeated on Day +1, +2 and +3
melphalan
"Dose of Melphalan + Palifermin (Normal Renal Function): All given on Day -2:~Dose Level 1- 200 mg/m2 I.V; Dose Level 2- 220 mg/m2 I.V; Dose Level 3- 240 mg/m2 I.V; Dose Level 4- 260 mg/m2 I.V; Dose Level 5- 280 mg/m2 I.V;~Dose of Melphalan + Palifermin (Renal Dysfunction CrCl. \<60)adm. via I.V.:~Dose Level 1- 140 mg/m2; Dose Level 2- 160 mg/m2; Dose Level 3- 180 mg/m2; Dose Level 4- 200 mg/m2; Dose Level 5- 220 mg/m2;"
questionnaire administration
Day -5 to Day +28
autologous peripheral blood stem cell transplantation
Day 0
quality-of-life assessment
Day -5 to Day +28
Barbara Ann Karmanos Cancer Institute, Detroit
National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER