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

被引:31
作者
Dispenzieri, A
Wiseman, GA
Lacy, MQ
Litzow, MR
Anderson, PM
Gastineau, DA
Tefferi, A
Inwards, DJ
Micallef, INM
Ansell, SM
Porrata, L
Elliott, MA
Lust, JA
Greipp, PR
Rajkumar, SV
Fonseca, R
Witzig, TE
Erlichman, C
Sloan, JA
Gertz, MA
机构
[1] Mayo Clin, Dept Internal Med, Div Hematol, Rochester, MN 55905 USA
[2] Mayo Clin, Dept Lab Med & Pathol, Div Clin Biochem & Immunol, Rochester, MN USA
[3] Mayo Clin, Dept Radiol Nucl Med, Rochester, MN USA
[4] Mayo Clin, Dept Pediat, Div Hematol Oncol, Rochester, MN USA
[5] Mayo Clin, Dept Lab Med & Pathol, Div Transfus Med, Rochester, MN USA
[6] Mayo Clin, Dept Lab Med & Pathol, Div Hematopathol, Rochester, MN USA
[7] Mayo Clin, Dept Internal Med, Div Hematol, Scottsdale, AZ USA
[8] Mayo Clin, Dept Med Oncol, Rochester, MN USA
[9] Mayo Clin, Dept Biostat, Rochester, MN USA
关键词
multiple myeloma; radiation; samarium; Quadramet (R); bone marrow; stem cell transplant;
D O I
10.1038/sj.leu.2403575
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Despite response rates of 30% after high-dose chemotherapy with autologous hematopoietic stem cell transplant, patients with multiple myeloma are not cured. (153)Samarium ethylene-diaminetetramethylenephosphonate (Sm-153-EDTMP; Quadramet((R))) is a short-range, beta-emitting therapeutic radiopharmaceutical with avid skeletal uptake. In total, 12 patients were treated with escalating doses of Sm-153-EDTMP (N=3/group; 6, 12, 19.8, and 30 mCi/kg) and a fixed dose of melphalan (200 mg/m(2)). 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 x 10(6)/I were 12 and 11 days, respectively, with no graft failures. Overall response rate was 94% including seven very good partial responses and five complete responses. Addition of Sm-153 EDTMP to melphalan conditioning appears to be safe, well-tolerated and worthy of further study.
引用
收藏
页码:118 / 125
页数:8
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