A Pharmacokinetic Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation



Status:Archived
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2010
End Date:November 2010

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A Phase IIA Open-Label, Randomized, Pharmacokinetic Comparative, Cross-Over Study of Melphalan HCL for Injection (Propylene Glycol-Free) and Alkeran for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation


To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene
Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing
autologous stem cell transplant (ASCT).


This study will be a multicenter, open-label, randomized, comparative, cross-over study of
high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection
conducted in 24 patients who have symptomatic MM and qualify for ASCT.

During the Study Period, patients will be randomized to receive 100mg/m2 of either Melphalan
HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection on Day -3 and the
alternate drug product on Day -2. Blood samples for pharmacokinetic (PK) evaluation will be
withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day
-2).

Following one day of rest after the myeloablative conditioning (Day -1), patients will
receive an autologous graft.


We found this trial at
2
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, KS
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