BMT-02: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Multiple Myeloma Following Initial Induction Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze
研究概览
简要总结
In this phase I trial, patients with 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 12Gy.
详细描述
To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant.
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 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 must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy
- •Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
- •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 myeloma who have had any disease progression prior to enrollment
- •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 allograft or autologous 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
Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
干预措施: Total Marrow Irradiation (Radiation)
Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
干预措施: Autologous Transplant (Procedure)
Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
干预措施: Melphalan (Drug)
Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
干预措施: Filgrastim (G-CSF) (Drug)
结局指标
主要结局
Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze
时间窗: Up to 1 year post-transplant.
To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
次要结局
未报告次要终点
研究者
Pritesh Patel, MD
Faculty, Assistant Professor
University of Illinois at Chicago