1. ¹Hematology Service, Division of Hematologic Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
2. ²Department of Clinical Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
3. ³Laboratory of Tumor Immunology and Immunotherapy, The Rockefeller University, New York, NY, USA
4. ⁴Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
5. ⁵Sloan-Kettering Institute, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Correspondence: Dr RL Comenzo, Howard 802, Memorial Sloan-Kettering Cancer Center, New York, NY, 1275 York Avenue, New York, New York 10021, USA. E-mail: comenzor@mskcc.org

Received 1 May 2005; Accepted 16 September 2005; Published online 1 December 2005.

Abstract

Autologous stem cell transplantation (SCT) with high-dose melphalan (HDM, 200 mg/m²) is the most effective therapy for multiple myeloma. To determine the feasibility of combining carmustine (300 mg/m²) with HDM, we enrolled 49 patients with previously treated Durie–Salmon stage II/III myeloma (32M/17W, median age 53) on a phase I/II trial involving escalating doses of melphalan (160, 180, 200 mg/m²). The median 2-microglobulin was 2.5 (0–9.3); marrow karyotypes were normal in 88%. The phase I dose-limiting toxicity was grade 2 pulmonary toxicity 2 months post-SCT. Other endpoints were response rate and progression-free survival (PFS). HDM was safely escalated to 200 mg/m²; treatment-related mortality was 2% and grade 2 pulmonary toxicity 10%. The complete (CR) and near complete (nCR) response rate was 49%. With a median post-SCT follow-up of 2.9 years, the PFS and overall survival (OS) post-SCT were 2.3 and 4.7 years. PFS for those with CR or nCR was 3.1 years while for those with stable disease (SD) it was 1.3 years (P=0.06). We conclude that carmustine can be combined with HDM for myeloma with minimal pulmonary toxicity and a high response rate.