An Open-label 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
- 62
- 主要终点
- Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
研究概览
简要总结
The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates.
详细描述
The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed, refractory patients with multiple myeloma (MM), based on response rates. Patients took SCIO-469 two capsules (60 mg) by mouth three times a day with water, preferably with a meal, for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy. On these days, the second dose of SCIO-469 was administered after collection of the 12-hour PK sample, and the third dose was not administered.
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
- •Life expectancy more than three months
- •diagnosed with multiple myeloma (MM)
- •relapsed following a response to any conventional MM therapy, and refractory to their most recent MM therapy
- •Karnofsky performance status = 60
- •no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
- •no history of myocardial infarction within last 6 months
- •serum concentrations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3X upper limit of normal (ULN)
- •total serum bilirubin = 2X ULN
- •Calculated or measured creatinine clearance >30 mL/min
- •platelet count = 30 x 10(9)/L
- •hemoglobin concentration = 8 g/dL
- •white blood cell count = 2.0 x 10(9)/L
排除标准
- •Patients with non-secretory myeloma, plasma cell leukemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes)
- •major surgery within four weeks of enrollment
- •severe elevated serum calcium
- •heart failure
- •receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
- •receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
- •known allergies to agents used in bortezomib (e.g., boron or mannitol)
- •poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
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 In addition to SCIO-469 patients with disease progression will receive bortesomib 1.0 mg/m2 intravenously as a bolus injection on Days 1 4 8 and 11 of a 21-day cycle followed by a 10-day rest period
干预措施: SCIO-469 and bortezomib (Drug)
结局指标
主要结局
Patient responses (CR, PR, MR, and overall response) are assessed using EBMT criteria, which primarily involve assessments of monoclonal paraprotein in the serum and urine and assessment of changes in soft tissue plasmacytomas and bone lesions.
时间窗: Day 73
次要结局
- Bone disease was monitored by assessing various markers.(Days 1, 15, 30, 52, 73)
- Size and number of lytic bone lesions were summarized.(screening and Day 73)
- Quality of life and pain was assessed.(Days 1, 15,30,52,73)
- Time to first response, time to best response, and percentage of patients with disease progression were assessed.(Days 1, 15, 30, 52, and 73)
- Performance status was evaluated.(Screening, Days 1, 30, 73)