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Myeloma

Results of a phase I/II trial adding carmustine (300 mg/m2) to melphalan (200 mg/m2) in multiple myeloma patients undergoing autologous stem cell transplantation

Leukemia volume 20, pages 345–349 (2006)Cite this article

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 β2-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.

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Acknowledgements

We thank the nursing staff and nurse practitioners in the out-patient clinics and particularly on MSKCC Medical 11 for the care they provide to our patients, and the MSKCC hematology fellows who have participated in the care of these patients. Grants and Support: This work was supported by NIH Grant CA05826, FDA Grant R03-002174, the Graziano Fund, the Mel Stottlemyre Myeloma Research Fund, the Donald Stein Myeloma Research Fund, and the Werner and Elaine Dannheiser Fund for Research on the Biology of Aging of the Lymphoma Foundation.

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Authors and Affiliations

  1. Division of Hematologic Oncology, Department of Medicine, Hematology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    R L Comenzo, H Hassoun, T Kewalramani, V Klimek, M Dhodapkar, L Reich & S D Nimer

  2. Department of Clinical Laboratory Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    R L Comenzo, M Fleisher & S D Nimer

  3. Laboratory of Tumor Immunology and Immunotherapy, The Rockefeller University, New York, NY, USA

    M Dhodapkar

  4. Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    J Teruya-Feldstein & D Filippa

  5. Sloan-Kettering Institute, Memorial Sloan-Kettering Cancer Center, New York, NY, USA

    S D Nimer

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  1. R L Comenzo
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Correspondence to R L Comenzo.

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Comenzo, R., Hassoun, H., Kewalramani, T. et al. Results of a phase I/II trial adding carmustine (300 mg/m2) to melphalan (200 mg/m2) in multiple myeloma patients undergoing autologous stem cell transplantation. Leukemia 20, 345–349 (2006). https://doi.org/10.1038/sj.leu.2404003

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