Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission.
PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.
详细描述
OBJECTIVES:
- Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib.
- Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone.
- Determine the toxicity of this drug in these patients (phase I).
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 2 following:
- •Intermediate- to high-M-component production rates (immunoglobulin [Ig]G > 5 g/dL or immunoglobulin A (IgA) > 3 g/dL or urine M component > 4 g/24 hours)
- •More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis
- •β-2 microglobulin > 3
- •Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30%
- •Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months
- •Age 18 to 69 years old
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 30,000/mm^3
- •serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 300 IU
- •Bilirubin ≤ 2 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •Creatinine clearance ≥ 30 mL/min
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- •concurrent major cardiac disease that would preclude study participation
- •concurrent major pulmonary disease that would preclude study participation
- •pregnant or nursing
- •peripheral neuropathy ≥ grade 2
- •history of hypersensitivity to bortezomib, boron, or mannitol
- •concurrent major gastrointestinal or bladder disease that would preclude study participation
- •concurrent major neurologic or psychiatric disease that would preclude study participation
- •dementia or significantly altered mental status that would preclude giving informed consent
- •prior interferon post-transplantation
- •prior thalidomide post-transplantation
- •prior chemotherapy post-transplantation
- •prior radiotherapy post-transplantation
- •prior investigational therapy post-transplantation
- •prior bortezomib
- •prior therapy for myeloma post-transplantation
- •other concurrent anti-myeloma therapy
- •other concurrent investigational therapy
研究组 & 干预措施
bortezomib
干预措施: bortezomib (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: signed consent to progression or end of trial. Up to 5 years.
Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (\~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.
次要结局
- Overall Survival(up to 5 years from time of consent)