Jantunen, E., Kuittinen, T., & Nousiainen, T. (2002). A pilot study on feasibility and efficacy of amifostine preceding high-dose melphalan with autologous stem cell support in myeloma patients. Leukemia and Lymphoma, 43, 1961–1965.

• Patients received 910 mg/m² IV amifostine as a 15-minute infusion prior to 200 mg/m² melphalan.
• Ten consecutive patients who were treated within the same protocol without amifostine were used as controls.
• Patients received granulocyte colony-stimulating factor (G-CSF) from day +4 to neutrophil recovery.

• The study reported on a sample of 20 patients.
• All patients were receiving 200 mg/m² high-dose melphalan and autologous stem-cell transplant (ASCT).
• Patients were given cytoxan, mesna and G-CSF for mobilization.

The study was conducted between November 1998 and February 2000.

This was a pilot, feasibility study.

The National Cancer Institute (NCI) Common Toxicity Criteria for Oral Mucositis was used to assess oral mucositis daily.

Most of the patients (9 out of 10) received the full dose of amifostine. One patient received only 780 mg/m² because of recurrent hypotension. Significant nausea, as well as hypotension and vomiting, occurred.

Amifostine did not show a benefit for gastrointestinal toxicity or mucositis of more than grade 2.

• This was a feasibility study.
• The sample size was small.