Randomized Comparison of Melphalan 200 Mg/m2 v. 280 Mg/m2 As a Preparative Regimen for Patients with Multiple Myeloma Undergoing Autologous Stem Cell Transplantation

• Published in: Blood 2012-11, Vol.120 (21), p.2009-2009
• Main Authors: Bensinger, William I., Becker, Pamela S, Gooley, Ted A., Chauncey, Thomas, Maloney, David G., Vescio, Robert, Gopal, Ajay K., Green, Damian J., Press, Oliver W., Lill, Michael, Holmberg, Leona, Ifthikharuddin, Jainulabdeen J, Phillips, Gordon L.
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V120.21.2009.2009

Abstract 2009 Melphalan 200 mg/m2 has remained the standard of care as a preparative regimen for patients with multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT). Higher doses of melphalan are associated with unacceptable gastrointestinal toxicity. Preliminary studies suggested that administration of the cytoprotective agent amifostine could protect patients with MM undergoing ASCT from excessive toxicity from doses of melphalan as high as 280 mg/m2. We conducted a prospective, multicenter, randomized trial comparing melphalan 200 mg/m2 (mel200) v. 280 mg/m2 (mel280) using amifostine pretreatment in patients with MM undergoing ASCT. The primary endpoints of the trial were grades 3–4 toxicity and near complete response (nCR) or better 60–120 days after ASCT. Eligibility included age ≤70, no prior ASCT, acceptable organ function, measurable monoclonal protein in serum or urine by protein electrophoresis and adequate stem cells for ASCT. Patients were stratified by ß2 microglobulin >5 at study entry, del 13 by FISH and response (