BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Gy
研究概览
简要总结
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard autologous stem cell transplant conditioned with high dose melphalan. In addition to Melphalan, the conditioning will include targeted total marrow irradiation (TMI). This is a conventional 3+3 phase I trial with increasing doses of TMI from minimum 3Gy to Maximum 9Gy.
详细描述
In this phase I trial, patients with relapsed or refractory multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 9Gy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting criteria for symptomatic myeloma
- •Patients who have progressive myeloma following initial induction (patients may have received any number of treatment regimens including prior autologous transplant)
- •Patient age 18-75 years at time of enrollment
- •Karnofsky performance status of ≥70
- •Cardiac function: LVEF >40%
- •Hepatic: Bilirubin <2x upper limit of normal and ALT and AST < 2.5x the upper limit of normal
- •Renal: Creatinine clearance of >30mL/min, estimated or calculated
- •Pulmonary: DLCO, FEV1, FVC >50% of predicted (after correction for hemoglobin)
排除标准
- •Patients with diagnosis of plasma cell leukemia
- •Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- •Pregnant or breast-feeding
- •Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
- •Patients who have undergone prior allogeneic stem cell transplant
- •Prior solid organ transplant
- •Patients receiving prior radiation to more than 20% of bone marrow containing areas
研究组 & 干预措施
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Total Marrow Irradiation (Radiation)
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Melphalan (Drug)
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Filgrastim (G-CSF) (Drug)
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Autologous transplant (Procedure)
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Total Marrow Irradiation (Radiation)
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Melphalan (Drug)
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Filgrastim (G-CSF) (Drug)
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Autologous transplant (Procedure)
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Total Marrow Irradiation (Radiation)
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Melphalan (Drug)
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Filgrastim (G-CSF) (Drug)
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
干预措施: Autologous transplant (Procedure)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Gy
时间窗: Up to 60 days post-transplant.
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
次要结局
- Progression Free Survival (PFS) and in Patients With Multiple Myeloma (Relapsed or Refractory) Undergoing Autologous Stem Cell Transplant Using the Combination of High Dose Melphalan and Total Marrow Irradiation(Up to 1 year post-transplant.)
研究者
Damiano Rondelli, MD
Professor
University of Illinois at Chicago