Phase II Study of MGTA-145 in Combination With Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests
研究概览
简要总结
This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize stem cells into the peripheral blood for collection by apheresis. The stem cells will be used for autologous stem cell transplant for treatment of multiple myeloma.
详细描述
PRIMARY OBJECTIVE
- To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (> 2 x 10e6 CD34+ cells/kg) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVES
- To assess the efficacy of MGTA-145 and plerixafor in mobilizing different Hematopoietic stem cells (HSCs) target goals in patients with MM in preparation for ASCT.
- To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in patients with MM.
- To assess the engraftment rate and time to engraftment following ASCT after HSC mobilization with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
- To assess rate of ongoing engraftment at Day 30 and 100 after stem cell infusion in patients with MM who are mobilized with MGTA-145 and plerixafor undergoing upfront ASCT.
- To assess transplant and disease-related outcomes after mobilization of HSCs with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma (MM) per the International Myeloma Working Group (IMWG) criteria
- •Eligible for autologous stem cell transplantation (ASCT) per institutional guidelines
- •Within 1 year of start of therapy for multiple myeloma
- •Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per institutional transplant guidelines
- •Calculated creatinine clearance > 30 mL/min, according to the Modification of Diet in Renal Disease (MDRD) formula.
- •Absolute neutrophil count (ANC) > 1500 x 10e6/L
- •Platelet count > 100,000 x 10e6/L
- •Ability to understand and the willingness to sign a written informed consent document.
- •Agreement to use an approved form of contraception for male patients or female patients of childbearing potential.
排除标准
- •History of prior stem cell transplant for multiple myeloma or other indications
- •Planned tandem stem cell transplant
- •Prior history of failure to collect HSCs.
- •Total bilirubin > 1.5x upper limit of normal (ULN) in the absence of a documented history of Gilbert's syndrome
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3x ULN
- •Known allergy to MGTA-145 or plerixafor.
- •Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6 cumulative months of treatment, ie, > 6 cycles of 28 days or > 8cycles of 21 days
- •Pregnant or lactating
研究组 & 干预措施
MGTA-145 and Plerixafor HSC Mobilization
Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session.
干预措施: MGTA-145 (Drug)
MGTA-145 and Plerixafor HSC Mobilization
Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session.
干预措施: Plerixafor (Drug)
结局指标
主要结局
Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests
时间窗: 2 days
The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). The primary outcome was assessed as the number of participants for whom 2.0 x 10e6 CD34+ HSC cells/kg could be collected in 1 or 2 apheresis harvests, after mobilization with MGTA-145 and Plerixafor. The outcome is reported as the number of participants who achieved this level of HSC cells, a number without dispersion.
次要结局
- Time To Platelet Engraftment ≥ 50 x 10e9/L(44 days)
- Infusion-related Toxicities(7 days after mobilization procedure)
- Time To Neutrophil Engraftment(15 days)
- Progression-free Survival (PFS)(100 days after infusion procedure)
- Non-relapse-related Mortality(100 days after infusion procedure)
- Overall Survival (OS)(100 days after infusion procedure)
- Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product(2 days)
- Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L](100 days)
- Time To Platelet Engraftment ≥ 20 x 10e9/L(33 days)
- Transplant-related Mortality(100 days after infusion procedure)
研究者
Surbhi Sidana, MD
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Stanford University