61
Participants
Start Date
December 31, 2012
Primary Completion Date
February 28, 2014
Study Completion Date
August 31, 2014
High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)
200 mg melphalan/m2 will be divided into two separate, consecutive doses of 100 mg/m2 administered on day -3 and day -2 prior to ASCT. The High-Dose Melphaln HCL for Injection (Propylene Glycol-Free) will be reconstituted to 5 mg/mL (also containing 270 mg/mL of Captisol®). The Melphalan HCL for Injection (Propylene Glycol Free) will be further diluted with normal saline to a concentration of no greater than 0.45 mg/mL and infused over 30 minutes ( + or - 3 minutes)via a central venous catheter.
Autologous Transplantation
Patients who are myeloablative conditioning in multiple myeloma undergoing autologous transplantation( patients own blood-forming stem cells are collected to replace diseased bone marrow or bone marrow damaged by cancer treatment)
Medical College of Wisconsin/Froedtert Hospital, Milwaukee
University of Wisconsin Hospital and Clinics, Madison
Rush University Medical Center, Chicago
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Fairway
University of Massachusetts, Worcester
Lead Sponsor
Collaborators (2)
Clinipace Worldwide
INDUSTRY
Beckloff Associates, Inc.
INDUSTRY
Kansas City Bioanalytical Laboratories
UNKNOWN
Acrotech Biopharma Inc.
INDUSTRY