EUCTR2009-016223-56-GB进行中（未招募）1 期
An Open-Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed and/or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed.
- •2. Signed either an IRB or IEC approved informed consent
- •3. ECOG performance status of = 2
- •4. Life expectancy of at least 3 months
- •5. M protein in either serum or urine, clonal bone marrow plasma cells >10%, and evidence of end organ damage
- •6. Adequate hematologic status, liver and renal function
- •7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. No anti-cancer treatment for = 4 weeks and no bortezomib treatment = 60 days prior to receiving study drug
- •2. Any other severe, acute or chronic illness
- •3. No other prior or concurrent malignancy
- •4. No immunosuppressant therapy
研究者
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