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, Martha Lacy, Mark R Litzow, P. M. Anderson, D. A. Gastineau, Ayalew Tefferi, D. J. Inwards, Ivana Micallef, Stephen Maxted Ansell, L. Porrata, M. A. Elliot, J. A. Lust, P. R. Greipp, S Vincent Rajkumar, Rafael Fonseca, Thomas Elmer Witzig, C. Erlichman, Jeff A Sloan, Morie 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

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Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Cancer Research

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