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临床试验/KCT0002985
KCT0002985尚未招募未知

Open-labeled, multicenter phase II study of prophylactic administration of pegylated granulocyte colony-stimulating factor in relapsed or refractory multiple myeloma who received pomalidomide/dexamethasone-containing regimens

Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
33

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 o Limit(—)
性别
All

入选标准

  • (1) Relapsed or refractory multiple myeloma who received pomalidomide and dexamethasone-containing regimen
  • (2) Absolute neutrophil count = 15,000/µL at screening
  • (3) Age = 19 years
  • (4) ECOG PS = 2
  • (5) Subjects must have signed an informed consent document indicating that they understand purpose
  • of and procedures required for the study and are willing to participate in the study.

排除标准

  • (1) Smoldering myeloma
  • (2) Primary or secondary plasma cell leukemia
  • (3) History of radiation therapy within 4 weeks prior to enrolment
  • (4) Patients who have hypersensitivity to pegfilgrastim
  • (5) Presence of abnormal result of baseline test
  • Platelet count < 50,000 cells/µL (50 x 109/L) (when patients do not received a blood transfusion)
  • Serum AST or ALT > 3 X normal range
  • (6) Renal failure with hemodialysis or peritoneal dialysis
  • (7) Presence of Uncontrolled severe infection
  • (8) Pregnant or lactating female

研究者

发起方
Chonnam National University Hospital Hwasun Hospital

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