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 |
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withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day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
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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