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临床试验/NCT01026701
NCT01026701已完成不适用

Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients.

Janssen Korea, Ltd., Korea0 个研究点目标入组 104 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
104
主要终点
bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)

研究概览

简要总结

The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.

详细描述

Among several symptoms in patients with multiple myeloma, the bone disease is one of the most common symptoms that approximately 80 percent of the patients experience. Multiple myeloma is different from other tumors in that several osteoclast activating factors (OAF) released from multiple myeloma cells resorb bone and, at the same time, activation of osteoblast is inhibited, leading to unbalance of breakdown and formation of bone. Activation of osteoclast and inhibition of osteoblast brings about bone fractures, osteoporosis, hypercalcemia, bone pain and spinal cord compression. Those symptoms are directly related to patients' quality of life. Therefore, they are the important therapeutic targets for multiple myeloma. Various types of bisphosphonate agents are used for the treatment of the bone disease in patients with multiple myeloma. This is a prospective (a study where the participants are identified and then followed forward in time), multi-center, Phase 4, observational study (studies that record specific events occurring without any intervention from the researcher) in order to analyze the change in bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) before and after the use of bortezomib injection by using an enzyme-linked immunosorbent assay (ELISA) in serum. The adverse events will be assessed through the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE V3). The patients will receive bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days under usual clinical practice.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included.

排除标准

  • Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity
  • Patients with severe hepatic impairment
  • Women who are pregnant

研究组 & 干预措施

001

bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

干预措施: bortezomib (Drug)

结局指标

主要结局

bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)

时间窗: on day 1 at the first cycle, and 12-24 weeks

次要结局

  • CR rate(at the end of every 3 week cycle)
  • Overall response rate(at the end of every 3 week cyclet)
  • Correlation between primary endpoints and response rate(12 -24 weeks)
  • NRS pain score(at the end of every 3 week cycle)
  • Adverse events(at the end of every 3 week cycle)

研究者

申办方类型
Industry
责任方
Sponsor

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