A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 5
- 主要终点
- Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
研究概览
简要总结
This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens:
Arm A = VELCADE, CYCLOPHOSPHAMIDE, & G-CSF Arm B = VELCADE & G-CSF Arm C = CYCLOPHOSPHAMIDE & G-CSF Arm D = PLERIXAFOR & G-CSF Arm E = PLERIXAFOR, VELCADE, & G-CSF
详细描述
PRIMARY STUDY OBJECTIVES
• To compare the efficacy of the following peripheral stem cell mobilization regimens for MM: i. High dose cyclophosphamide, VELCADE, and G-CSF ii. VELCADE and G-CSF iii. High dose cyclophosphamide and G-CSF
SECONDARY STUDY OBJECTIVES
• To evaluate biomarkers as surrogate markers of mobilization in each arm To evaluate changes in tumor mass as defined by standard response parameters. To evaluate the safety of each of the arms.
This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy
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
- •Voluntary written informed consent
- •Confirmed diagnosis of multiple myeloma
- •Age > than 18 years at the time of signing the informed consent form.
- •Karnofsky performance status above 60%
- •Patients must be within 30 days of completing induction therapy.
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
- •Male subject agrees to use an acceptable method for contraception for the duration of the study.
- •Life expectancy > 12 weeks.
- •Subjects must have a MUGA scan or echo with LVEF >50%
- •Subjects must meet the following laboratory parameters:
- •Absolute neutrophil count (ANC) ≥1500 cells/mm3
- •Platelets count ≥ 50,000/mm3
- •Hemoglobin > 9.0 g/dL
- •Serum SGOT/AST <3.0 x upper limits of normal (ULN)
- •Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
- •Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min
- •Serum total bilirubin < 1.5 x ULN
排除标准
- •Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
- •History of allergic reactions to compounds containing boron, mannitol, VELCADE
- •Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for > = 5 years.
- •NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- •Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- •Known HIV or hepatitis A, B, or C positivity---ONLY IF ACTIVE
- •Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
- •Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk
- •Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
- •Patient has received other investigational drugs with 14 days before enrollment
- •Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
研究组 & 干预措施
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
干预措施: bortezomib (Velcade) (Drug)
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
干预措施: cyclophosphamide (Drug)
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
干预措施: G-CSF (Drug)
Arm B: VELCADE & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
干预措施: bortezomib (Velcade) (Drug)
Arm B: VELCADE & G-CSF
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
干预措施: G-CSF (Drug)
Arm C: CYCLOPHOSPHAMIDE & G-CSF
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
干预措施: cyclophosphamide (Drug)
Arm C: CYCLOPHOSPHAMIDE & G-CSF
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
干预措施: G-CSF (Drug)
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
干预措施: G-CSF (Drug)
Arm D: PLERIXAFOR & G-CSF
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
干预措施: Plerixafor (Drug)
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
干预措施: bortezomib (Velcade) (Drug)
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
干预措施: G-CSF (Drug)
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.
Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
干预措施: Plerixafor (Drug)
结局指标
主要结局
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
时间窗: 36 months
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.
次要结局
- Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant(20 days post-transplant)
- Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant(20 days post-transplant)