Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
研究概览
简要总结
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
详细描述
PRIMARY OBJECTIVES:
I. Ability to reach target collection of 5 x 10^6 CD34+ cells/Kg with =< 2 days of leukaphereses using one of two mobilization regimens.
SECONDARY OBJECTIVES:
I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =< 5 days of leukaphereses.
II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MM by International Myeloma Working Group Criteria
- •In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood & Marrow Transplant Research
- •Received at least 2 cycles of lenalidomide therapy
- •Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT)
- •At least 2 weeks since last exposure to lenalidomide
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Prior to the start of mobilization:
- •white blood cell count >/= 2.5 x 10^9/L
- •absolute neutrophil count >/= 1.2 x 10^9/L
- •platelet count >/=100 x 10^9/L
- •creatinine clearance >/= 30mL/minute
- •If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy
排除标准
- •Had prior autologous or allogeneic transplantation
- •Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization
- •Failed previous hematopoietic stem cell collections or collection attempts
- •Received radiation therapy to the pelvic area
- •Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization
- •Had received experimental therapy within 4 weeks of enrolling in study
- •Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
研究组 & 干预措施
Arm I
Patients receive G-CSF SC QD on days 1-4.
干预措施: filgrastim (Biological)
Arm II
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
干预措施: filgrastim (Biological)
Arm II
Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
干预措施: plerixafor (Drug)
结局指标
主要结局
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
时间窗: In =< 2 days of leukaphereses
次要结局
- Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other(By day 1)
- Compare Need for Remobilization Between Mobilization Groups(Day 1)
- Percentage of Patients Achieving Target Goal CD34+ Cells Dose(In =< 5 days of leukaphereses)
- Compare Days of Apheresis Between Mobilization Groups(Day 1)
- Compare Need for Hospitalization During Mobilization Between Mobilization Groups(Day 1)