32
Participants
Start Date
January 31, 2007
Primary Completion Date
December 31, 2013
Study Completion Date
December 31, 2013
Bortezomib 1 mg/m2
"* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line~* Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1~* Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen"
Bortezomib 1.3 mg/m2
"* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line~* Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1~* Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen"
Bortezomib 1.6 mg/m2
"* Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line~* Bortezomib will be administered any time on day -4 and 24 hrs after the start of the melphalan infusion on day -1~* Dosing will be based on actual body weight Patient weight must be measured within seven days of the start of the treatment regimen"
Melphalan
"* Melphalan is administered by rapid intravenous infusion via a central or peripheral vein over one hour~* Melphalan will be dissolved with 10 ml of diluent to a concentration of 5 mg/mL which is then immediately diluted in 0.9% normal saline to a concentration NOT exceeding 0.45 mg/mL prior to administration~* The final dilution of melphalan is physically and chemically stable for 60 minutes and therefore will be administered within that time period~* Melphalan will be given as a single dose (not split over 2 or more days)~* Dosing will be based body surface area calculated using actual body weight"
Hackensack University Medical Center, Hackensack
Hackensack Meridian Health
OTHER