Multi-Center,Open-Label,Randomized,Phase 1B Study Evaluating Safety & Tolerability of Intravenous rhMBL in Pts With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Safety and tolerability of rhMBL
研究概览
简要总结
MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.
详细描述
MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v. infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL arms, and 10 patients will receive best standard supportive prophylactic therapy but not rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 must meet all of the following criteria to be eligible for enrollment into the study:
- •Capable of understanding the protocol requirements and risks and providing written informed consent.
- •Histologically or cytologically confirmed diagnosis of multiple myeloma.
- •Mannose-binding lectin level <300 ng/mL.
- •Age ≥18 years old.
- •Score of 0 to 2 on the Zubrod performance status scale.
- •Patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous HSCT for the treatment of multiple myeloma.
排除标准
- •Concurrent serious medical illness that could potentially interfere with protocol compliance.
- •Concurrent or previous malignancy associated with a poor prognosis.
- •Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus [HIV] will not be performed).
- •Positive screening pregnancy test or is breast-feeding.
- •Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
- •Known or clinically suspected active brain metastases.
- •Current participation in another clinical study with an investigational agent and/or use of an investigational drug.
研究组 & 干预措施
0 mg/kg
干预措施: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) (Drug)
0.5 mg/kg
干预措施: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) (Drug)
1.0 mg/kg
干预措施: Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) (Drug)
结局指标
主要结局
Safety and tolerability of rhMBL
时间窗: 2 months
次要结局
- Pharmacokinetic (PK) of rhMBL(2 months)
- Pharmacodynamics (PD) of rhMBL(2 months)
- Immunogenicity of rhMBL, incidence of infectious complications(2 months)