Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma
2010年10月21日 更新者：Scios, Inc.
A 24-week, Open-label Extension Study of the Efficacy, Safety, and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma
The main objective of this study is to assess the long-term effectiveness of SCIO-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.
研究概览
详细说明
The main objective of this study is to assess the long-term efficacy of SCIO-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.
Patients took by mouth two capsules (60 mg) three times a day alone or in combination with bortezomib, for 168 days.
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients who did not have disease progression on Day 73 of Study B003
- patients fully understand all elements of, and have signed and dated, the written Informed Consent Form (ICF) before initiation of protocol-specified procedures
Exclusion Criteria:
- Patients who have an active uncontrolled infection
- any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk to participate in the study
- pregnant or lactating women, or who are not using adequate contraception
- sexually active women of childbearing potential (WCBP) who do not agree to use at least two forms of medically accepted birth control, including one barrier method, for the duration of the study
- men who do not agree to use an acceptable method for contraception throughout the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：001
SCIO-469 两粒 30 毫克胶囊，每日三次
|
每天 3 次，每次 2 粒 30 毫克胶囊
|
|
有源比较器：002
SCIO-469 and bortezomib The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
|
The addition of bortezomib (treatment regimen or bolus) to monotherapy of SCIO-469 or bortezomib combination with SCIO-469 will be dependent upon clinical response or disease progression during the study
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
大体时间：Baseline to Day 168
|
Baseline to Day 168
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Time to first response and time to best response
大体时间：Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
|
Size and number of lytic bone lesions were summarized.
大体时间：Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
|
Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.
大体时间：Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
|
Performance status was evaluated by Karnofsky scale.
大体时间：Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
|
Bone disease was monitored by assessing various biomarkers.
大体时间：Baseline, Wks 6,12,18,24, Day 198
|
Baseline, Wks 6,12,18,24, Day 198
|
|
Number of patients with disease progression
大体时间：Wks 6,12,18,24, Day 198
|
Wks 6,12,18,24, Day 198
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年11月1日
研究完成 (实际的)
2006年2月1日
研究注册日期
首次提交
2004年11月5日
首先提交符合 QC 标准的
2004年11月5日
首次发布 (估计)
2004年11月8日
研究记录更新
最后更新发布 (估计)
2010年10月22日
上次提交的符合 QC 标准的更新
2010年10月21日
最后验证
2010年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.