A phase 1 study of 153Sm-EDTMP with fixed high-dose melphalan as a peripheral blood stem cell conditioning regimen in patients with multiple myeloma

Angela Dispenzieri, G. A. Wiseman, M. Q. Lacy, M. R. Litzow, P. M. Anderson, D. A. Gastineau, A. Tefferi, D. J. Inwards, I. N.M. Micallef, S. M. Ansell, L. Porrata, M. A. Elliot, J. A. Lust, P. R. Greipp, S. V. Rajkumar, R. Fonseca, T. E. Witzig, C. Erlichman, J. A. Sloan, M. A. Gertz

Research output: Contribution to journalArticle

36 Scopus citations

Abstract

Despite response rates of 30% after high-dose chemotherapy with autologous hematopoietic stem cell transplant, patients with multiple myeloma are not cured. 153Samarium ethylenediaminetetramethylenephosphonate (153Sm-EDTMP; Quadramet®) is a short-range, β-emitting therapeutic radiopharmaceutical with avid skeletal uptake. In total, 12 patients were treated with escalating doses of 153Sm-EDTMP (N=3/group; 6, 12, 19.8, and 30 mCi/kg) and a fixed dose of melphalan (200 mg/m2). No dose limiting toxicity was seen. To better standardize the marrow compartment radiation dose, the study was modified such that an additional six patients were treated at a targeted absorbed radiation dose to the red marrow of 40 Gy based on a trace labeled infusion 1 week prior to the therapy. Despite rapid elimination of unbound radiopharmaceutical via kidneys and bladder, no episodes of nephrotoxicity, hemorrhagic cystitis, or delayed radiation nephritis were observed with a median follow-up of 31 months (range 8.5-44). Median times to ANC>0.5 and platelet >20 × 106/I were 12 and 11 days, respectively, with no graft failures. Overall response rate was 94% including seven very good artial responses and five complete responses. Addition of 153Sm EDTMP to melphalan conditioning appears to be safe, well-tolerated and worthy of further study.

Original languageEnglish (US)
Pages (from-to)118-125
Number of pages8
JournalLeukemia
Volume19
Issue number1
DOIs
StatePublished - Jan 2005

Keywords

  • Bone marrow
  • Multiple myeloma
  • Quadramet®
  • Radiation
  • Samarium
  • Stem cell transplant

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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