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
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withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day
Following one day of rest after the myeloablative conditioning (Day -1), patients will
receive an autologous graft.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) versus Alkeran for Injection in MM patients undergoing ASCT.
0,10,20,30,60,90,120,180,240,360,480 minutes after completion of each infusion
Omar Aljitawi, MD
University of Kansas
United States: Food and Drug Administration
|University of Kansas Medical Center/University of Kansas Cancer Center and Medical Pavillion||Kansas City, Kansas 66160|