A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 7
- 主要终点
- To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
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
- •Confirmed diagnosis of Multiple Myeloma
- •Men and Women at least 18 years old
- •ECOG status 0-2
- •Last therapeutic or diagnostic treatment at least 21 days prior
- •Bone marrow transplants must have been completed at least 3 months prior
- •Any toxicity from prior therapies must have resolved to Grade ≤1
排除标准
- •Women pregnant or breastfeeding
- •WOCBP unwilling/unable to use acceptable method to avoid pregnancy
- •Uncontrolled medical disorder or active infection
- •Current or recent (w/in 3 months) gastrointestinal disorder
- •Inability to swallow oral medication
- •Inability to be venipunctured
- •Uncontrolled or significant cardiovascular disease
- •Uncontrolled hyperlipidemia
- •Intolerance of lenalidomide or bortezomib if participating in Arms B and C
- •Concurrent therapy with any other investigational product
- •Subjects involuntary incarcerated
- •Subjects detained for treatment of psychiatric or physical illness
研究组 & 干预措施
Arm 1
BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
干预措施: BMS-833923 (Drug)
Arm 2
BMS-833923 (MTD or below)
Lenalidomide (at or below the recommended prescribing dose)
Dexamethasone (40 mg)
干预措施: BMS-833923 (Drug)
Arm 2
BMS-833923 (MTD or below)
Lenalidomide (at or below the recommended prescribing dose)
Dexamethasone (40 mg)
干预措施: Lenalidomide (Drug)
Arm 2
BMS-833923 (MTD or below)
Lenalidomide (at or below the recommended prescribing dose)
Dexamethasone (40 mg)
干预措施: Dexamethasone (Drug)
Arm 3
BMS-833923 (MTD or below)
Bortezomib (at or below the recommended prescribing dose)
干预措施: BMS-833923 (Drug)
Arm 3
BMS-833923 (MTD or below)
Bortezomib (at or below the recommended prescribing dose)
干预措施: Bortezomib (Drug)
结局指标
主要结局
To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
时间窗: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
次要结局
- To evaluate the Pharmacokinetics of BMS-833923(For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles)
- To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib(For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles)
- To evaluate the Pharmacodynamics effects of BMS-833923(For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles)