A Pilot, Exploratory, Randomized, Phase 2 Safety Study Evaluating Tumor Cell (Plasma Cell) Mobilization and Apheresis Product Contamination in Plerixafor Plus Non-pegylated G-CSF Mobilized Patients and in Non-pegylated G-CSF Alone Mobilized Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
研究概览
简要总结
The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
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 with a diagnosis of MM in partial response or complete response, who are undergo an autologous hematopoietic stem cell transplantation and could be considered potentially poor mobilizers.
排除标准
- •Does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
- •Had prior allogeneic or autologous transplantation.
- •Less than 3 to 6 weeks since last anti-cancer therapy.
- •Chemotherapy for mobilization is not allowed.
- •Has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF.
- •Was treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
- •Has previously received plerixafor.
- •Is known to be HIV positive.
- •Has active hepatitis B or hepatitis C.
- •Has an acute infection within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
- •Has hypercalcaemia as evidenced by >1 mg/dL above upper limit of normal (ULN).
- •Previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
- •Has central nervous system involvement including brain metastases or leptomeningeal disease.
- •Has an electrocardiogram (ECG) or study result indicative of cardiac ischemia or a history of clinically significant rhythm disturbance(arrhythmias), or other conduction abnormality.
- •Has co-morbid condition(s), which may render the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol.
- •Has a white blood cell (WBC) count <2.5 x 10^9/L.
- •Has an absolute neutrophil count (ANC) <1.5 x 10^9/L.
- •Has a platelet count <100 x 10^9/L.
- •Has an estimated creatine clearance ≤50 mL/min.
- •Has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x ULN.
- •Does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation.
- •Pregnant or breastfeeding women.
- •Does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment.
研究组 & 干预措施
G-CSF alone
Patients will receive G-CSF for 5 consecutive days
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
G-CSF plus plerixafor
Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF
干预措施: Plerixafor (Drug)
G-CSF plus plerixafor
Patients will receive G-CSF for 4 consecutive days, then receive plerixafor before the 5th dose of G-CSF
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
结局指标
主要结局
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
时间窗: Day 1 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
时间窗: Day 5 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
时间窗: Day 5 to Day 8 of the apheresis/treatment period
Peripheral blood parameters
The change in tumor cell mobilization(TCM) in the peripheral blood
时间窗: Day 4 pre-G-CSF to Day 5 pre-G-CSF
Peripheral blood parameters
The number of myeloma tumor cells per patient at each apheresis
时间窗: Day 1 to Day 8 of the apheresis/treatment period
Apheresis product parameters
The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product
时间窗: Day 5 to Day 8 of the apheresis/treatment period
Apheresis product parameters
次要结局
- CD34+ stem cell yield in the apheresis product(Day 1 to Day 8 of the apheresis/treatment period)
- The number of patients that proceed to transplantation(Up to 2 months after final apheresis)
- Overall survival(Day 100 post transplant and up to 2 years post first-G-CSF dose)