Thieblemont, V.C., Dumontet, C., Saad, H., Roch, N., Bouafia, F., Arnaud, P., … Coiffier, B. (2002). Amifostine reduces mucosal damage after high-dose melphalan conditioning and autologous peripheral blood progenitor cell transplantation for patients with multiple myeloma. Bone Marrow Transplantation, 30, 769–775.

DOI Link

Intervention Characteristics/Basic Study Process

Patients in the study group received 740 mg/m2 IV amifostine prior to 200 mg/mmelphalan.

Sample Characteristics

  • The study reported on a sample of 41 patients, out of which 21 received amifostine and 20 were analyzed as controls.
  • Patients were diagnosed with stage 3 multiple myeloma (MM) and receiving high-dose 200 mg/m2 melphalan and autologous peripheral stem cell transplant.
  • Median age of patients was 56 years with a range of 27–68.

Setting

This study was conducted betwen September 1999 and December 2001.

Study Design

This was a prospective, comparative, non-randomized controlled, phase 2 trial conducted at a single institution.

Measurement Instruments/Methods

  • The World Health Organization mucositis scale was used.
  • Opioid use was recorded.
  • Delayed gastrointestinal side effects were reported.

Results

  • Fewer patients in the amifostine group experienced grade 2–4 mucositis (33% versus 65%, p = 0.047).
  • No cases of grade 3-4 mucositis were reported in the amifostine arm.

Limitations

  • The sample size and study population were small.
  • A large number of patients experienced emesis (43%).
  • Limited mucositis data was included.