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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Scios, Inc.
- 入组人数
- 30
- 主要终点
- Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
001
SCIO-469 two 30-mg capsules three times daily
干预措施: SCIO-469 (Drug)
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
干预措施: SCIO-469 and bortezomib (Drug)
结局指标
主要结局
Rate of response during therapy as measured by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
时间窗: Baseline to Day 168
次要结局
- Time to first response and time to best response(Baseline, Wks 6,12,18,24, Day 198)
- Size and number of lytic bone lesions were summarized.(Baseline, Wks 6,12,18,24, Day 198)
- Pain was assessed by Pain Intensity Categorical Scale and Pain Intensity Visual Aid Scale.(Baseline, Wks 6,12,18,24, Day 198)
- Performance status was evaluated by Karnofsky scale.(Baseline, Wks 6,12,18,24, Day 198)
- Bone disease was monitored by assessing various biomarkers.(Baseline, Wks 6,12,18,24, Day 198)
- Number of patients with disease progression(Wks 6,12,18,24, Day 198)