NCT03406091已完成不适用
Detection of Poor Mobilizer (PM) in Multiple Myeloma (MM) Patients: Prospective Product Registry
Fondazione EMN Italy Onlus1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年11月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Assessment of success rate expressed as % of patients mobilizing ≥2x106 CD34+ cells/kg in maximum 3 apheresis and patient who achieves the optimal target of 4x106 CD34+ cells/kg up to 5 apheresis.
研究概览
简要总结
The study is an italian multicentric and will be conducted in 20 centers. The aim of this study is to evaluate poor mobilizer (PM) rate in newly diagnosed MM patients who are mobilized with cyclophosphamide and G-CSF and plerixafor on demand.
Plerixafor is a specific reversible inhibitor of the chemokine receptor CXCR4 and prevents the binding of its ligand stromal cell derived factor SDF-1α also known as CXCL12, thereby releasing hematopoietic stem cells into the circulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Newly diagnosed transplant eligible MM patients
- •Measurable disease as defined by the presence of M-protein in serum or urine, or abnormal free light chain ratio
- •Eligible and planned for HDT and autologous haematopoietic stem cell transplantation
- •≥18 years of age
- •Patients or their legally authorized representatives must provide written informed consent
- •Mobilization performed with G-CSF 2-4 g/m2 of cyclophosphamide and Plerixafor On Demand if considered needed based on center policies
- •Patients can be included in interventional clinical trials
- •Karnofsky performance status ≥ 60%
- •Total bilirubin < 1.5 upper limit of normal (ULN)
- •AST/SGOT and ALT/SGPT < 2.5 upper limit of normal (ULN)
- •Serum creatinine < 2 upper limit of normal (ULN)
- •WBC count ≥2.5x109/L
- •ANC count ≥1.5x109/L
- •Platelet count ≥75x109/L
- •Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
- •Women are not breast feeding and not pregnant
- •A negative pregnancy test is required for women in child-bearing age; patients must agree to use an adequate method of contraception whilst on study treatment and for 3 months following plerixafor treatment
排除标准
- •Relapse/refractory MM patients
- •Non secretory MM
- •Primary plasmacell leukemia.
- •Prior allogeneic or autologous transplantation.
- •Prior failed mobilization attempt.
- •Inability to tolerate PBPC harvest.
- •Peripheral venous access not possible.
- •Pregnant or nursing women or patients unwilling to have adequate contraception up to 3 months after end of treatment with plerixafor
- •Clinical active infectious hepatitis type A, B, C or HIV
- •Acute infection (febrile, i.e. temperature > 38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
- •Left ventricular ejection fraction < 50%.
- •Splenectomised or splenic irradiation.
- •Psychiatric, addictive, or any disorder/disease which compromises ability to give truly informed consent for participation in this study and renders the patient at high risk from treatment complications or impairs the ability to comply with the study treatment and protocol.
- •Treatment with G-CSF or other cytokine within 2 weeks prior to the first dose of G-CSF for mobilization.
- •Patients previously treated with Plerixafor
- •Patients mobilised with chemotherapy other than cyclophosphamide 2 et 4 gr/m2
- •Patients mobilised with growth factors at a dose other than (5-10µg/kg)
研究组 & 干预措施
Poor Mobilizer (PM) in Multiple Myeloma (MM) patients
干预措施: Plerixafor (Drug)
结局指标
主要结局
Assessment of success rate expressed as % of patients mobilizing ≥2x106 CD34+ cells/kg in maximum 3 apheresis and patient who achieves the optimal target of 4x106 CD34+ cells/kg up to 5 apheresis.
时间窗: 3 years
次要结局
- % of patients having received plerixafor in the study population(3 years)
- Confirmation of factors predicting a poor mobilization: patients who experienced grade 3-4 haematological toxicity during induction, used lenalidomide as induction treatment, aged > 60 years old and experienced cytopenia at diagnosis.(3 years)
- Evaluate in patients failing mobilisation how many of them received plerixafor and how many did not(3 years)
- Evaluation of speed of mobilization using plerixafor, in terms of increase in number of circulating CD34+ cells from time 0 to 6-11 hours after the first dose of plerixafor.(3 years)
- Total number of CD34+ cells collected per apheresis day(3 years)
研究者
研究点 (1)
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