Spencer, A., Horvath, N., Gibson, J., Prince, H.M., Herrmann, R., Bashford, J., … Taylor, K. (2005). Prospective randomized trial of amifostine cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell transplantation. Bone Marrow Transplantation, 35, 971–977.

Patients in the study group received 910 mg/m² IV amifostine 15–30 minutes prior to  200 mg/m² melphalan prior to autotransplant for multiple myeloma (MM). 

• The study reported on a sample of 90 patients; 43 patients received amifostine, and 47 did not.
• The age range was 31–69 years with a median age of 54 years.

This was a multicenter study conducted between May 1999 and November 2000.

This was an open label, randomized study.

The World Health Organization (WHO) scale for mucositis, median duration of mucositis, duration of total parenteral nutrition (TPN), and duration of narcotics use were recorded.

• Patients in the amifostine group experienced a reduction in median grade of maximal mucositis and incidence of grades 2–4 mucositis compared to the control group. 
• Patients in the amifostine group were more likely to experience no mucositis than patients in the control group, although the difference was not significant.
• Median duration of maximal severity was 3 days in the control group and 4 days in the amifostine group (p = 0.18).
• The control group was more likely to experience severe delayed emesis compared to the amifostine group, although this difference was not significant. 
• No significant differences were found in the requirement for or duration of TPN or narcotics.

This study provided weak statistical evidence for the use of amifostine.

• This study was supported by Schering Plough, which also manufactured amifostine, and Amgen.
• Amifostine infusion toxicities were common in this study.