(PRO#11307) Phase III Randomized Study of Autologous Stem Cell Transplantation With High-dose Melphalan Versus High-dose Melphalan and Bortezomib in Patients With Multiple Myeloma 65 Year or Older
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Progression Free Survival Rate
研究概览
简要总结
In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.
详细描述
In this study the investigators are comparing this standard regimen to the newly established regimen of melphalan and bortezomib.
Conditioning Regimens:
Treatment arm A Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple myeloma less than 12 months since initiation of systemic therapy
- •Age ≥60 years at time of transplantation
- •KPS 70-100%
- •Recovery from complications of prior therapy
排除标准
- •Diagnosis other than multiple myeloma
- •Chemotherapy or radiotherapy within 8 days of initiating treatment in this study
- •Prior dose-intense therapy within 56 days of initiating treatment in this study
- •Uncontrolled bacterial, viral, fungal or parasitic infections
- •Uncontrolled CNS metastases
- •Known amyloid deposition in heart
- •Organ dysfunction
- •LVEF <40% or cardiac failure not responsive to therapy
- •FVC, FEV1 or DLCO < 40% of predicted and/or receiving supplementary continuous oxygen
- •Evidence of hepatic synthetic dysfunction or total bilirubin > 2x or AST > 3x ULN
- •Measured creatinine < 20ml/min
- •Sensory peripheral neuropathy grade 4 within 14 days of enrollment
- •Karnofsky score < 70%
- •Life expectancy limited by other co-morbid illnesses
研究组 & 干预措施
Treatment A
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
Stem cell infusion:
Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.
Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).
干预措施: Melphalan (Drug)
Treatment Arm B
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Progression Free Survival Rate
时间窗: Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely
Progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib at 3 years
次要结局
- Overall Survival Rate(1 year)