Conflict of interest: Nothing to report.
A Phase II study of 153Sm-EDTMP and high-dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma†
Article first published online: 2 MAR 2010
Copyright © 2010 Wiley-Liss, Inc.
American Journal of Hematology
Volume 85, Issue 6, pages 409–413, June 2010
How to Cite
Dispenzieri, A., Wiseman, G. A., Lacy, M. Q., Hayman, S. R., Kumar, S. K., Buadi, F., Dingli, D., Laumann, K. M., Allred, J., Geyer, S. M., Litzow, M. R., Gastineau, D. A., Inwards, D. J., Micallef, I. N., Ansell, S. M., Porrata, L., Elliott, M. A., Johnston, P. B., Hogan, W. J. and Gertz, M. A. (2010), A Phase II study of 153Sm-EDTMP and high-dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma. Am. J. Hematol., 85: 409–413. doi: 10.1002/ajh.21696
- Issue published online: 25 MAY 2010
- Article first published online: 2 MAR 2010
- Accepted manuscript online: 2 MAR 2010 12:00AM EST
- Manuscript Accepted: 22 FEB 2010
- Manuscript Received: 16 FEB 2010
- Mayo Clinic Hematology Malignancies Program. Grant Numbers: M01-RR00585, CA15083
Multiple myeloma (MM) remains an incurable illness affecting nearly 20,000 individuals in the United States per year. High-dose melphalan (HDM) with autologous hematopoietic stem cell support (ASCT) is one of the mainstays of therapy for younger patients, but little advancement has been made with regards to conditioning regimens. We opted to combine 153Samarium ethylenediaminetetramethylenephosphonate (153Sm-EDTMP), a radiopharmaceutical approved for the palliation of pain caused by metastatic bone lesions, with HDM and ASCT in a Phase II study. Individualized doses of 153Sm were based on dosimetry and were calculated to deliver 40 Gy to the bone marrow. The therapeutic dose of 153Sm-EDTMP was followed by HDM and ASCT. Forty-six patients with newly diagnosed or relapsed disease were treated. Study patients were compared to 102 patients contemporaneously treated with HDM and ASCT. Fifty-nine percent of study patients achieved a very good partial response (VGPR) or better. With a median follow-up of 7.1 years, the median overall survival and progression free survival (PFS) from study registration was 6.2 years (95% CI 4.6–7.5 years) and 1.5 years (1.1–2.2 years), respectively, which compared favorably to contemporaneously treated non-study patients. Addition of high-dose 153Sm-EDTMP to melphalan conditioning appears to be safe, well tolerated, and worthy of further study in the context of novel agents and in the Phase III setting. Am. J. Hematol. 2010. © 2010 Wiley-Liss, Inc.