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A Phase II study of 153Sm-EDTMP and high-dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma†

  1. Angela Dispenzieri1,2,*,
  2. Gregory A. Wiseman3,
  3. Martha Q. Lacy1,
  4. Suzanne R. Hayman1,
  5. Shaji K. Kumar1,2,
  6. Francis Buadi1,
  7. David Dingli1,
  8. Krista M. Laumann4,
  9. Jake Allred4,
  10. Susan M. Geyer5,
  11. Mark R. Litzow1,
  12. Dennis A. Gastineau1,2,
  13. David J. Inwards1,
  14. Ivana N. Micallef1,
  15. Stephen M. Ansell1,
  16. Luis Porrata1,
  17. Michelle A. Elliott1,2,
  18. Patrick B. Johnston1,
  19. William J. Hogan1,
  20. Morie A. Gertz1

Article first published online: 2 MAR 2010

DOI: 10.1002/ajh.21696

Issue

American Journal of Hematology

American Journal of Hematology

Volume 85, Issue 6, pages 409–413, June 2010

Additional Information

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

Author Information

  1. 1

    Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota

  2. 2

    Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota

  3. 3

    Department of Radiology (Nuclear Medicine), Mayo Clinic, Rochester, Minnesota

  4. 4

    Department of Biostatistics, Mayo Clinic, Rochester, Minnesota

  5. 5

    Department of Biostatistics, Ohio State University, Columbus, Ohio

*Mayo Clinic, 200 First Street SW, Rochester, MN 55905

  1. †

    Conflict of interest: Nothing to report.

Publication History

  1. Issue published online: 25 MAY 2010
  2. Article first published online: 2 MAR 2010
  3. Accepted manuscript online: 2 MAR 2010 12:00AM EST
  4. Manuscript Accepted: 22 FEB 2010
  5. Manuscript Received: 16 FEB 2010

Funded by

  • Mayo Clinic Hematology Malignancies Program. Grant Numbers: M01-RR00585, CA15083

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Abstract

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.

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