NCT01838369终止2 期
A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria
研究概览
简要总结
The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:
- •Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent.
- •Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.
- •Male or female, 18 years or older.
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
排除标准
- •Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.
- •Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.
- •Severe other conditions.
研究组 & 干预措施
BI-505
Experimental
干预措施: BI-505 (Drug)
结局指标
主要结局
To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria
时间窗: M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.
次要结局
- The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.(At each visit and up to 28 days after the last dose.)
- The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.(Up to 28 days after the last dose.)
- The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.(Up to 28 days after the last dose.)
- The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.(Prior to first dose and at 28 days after the final dose.)
研究者
研究点 (1)
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