UARK 2003-25: A Phase I/II Open Label Study of IV Busulfan (Busulfex®) in Multiple Myeloma Patients Older Than 65 Years of Age or With Renal Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients
研究概览
简要总结
The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in patients with poor kidney function and patients over the age of 65 when given in high doses.
详细描述
This trial will determine the maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are > or = 65 years of age or have renal insufficiency, defined as creatinine > 3g/dL or creatinine clearance < 30 ml/min.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have symptomatic multiple myeloma requiring treatment
- •Patients must have been approved for single or tandem autologous transplant
- •Patients must be > or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute
- •Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted,
- •Patients must have an ECHO or MUGA performed within 60 days prior to registration, LVEF > 40%.
- •Bilirubin, SGOT, SGPT must be less than 1.5 times the upper limit of normal
- •Patients must have evaluable myeloma marker for response such as: *Serum M protein >1g/dl or urine M protein >1g/24 hours and/or; *Bone marrow plasmacytosis with >20% plasma cells and/or; *Extramedullary plasmacytosis; *MRI/PET scan has focal lesions due to myeloma.
- •Patients must be able to receive full doses of DT-PACE, in the opinion of the treating investigator, with the exception of cisplatin.
- •Patients must have a performance status of 0-2 based on SWOG criteria unless the patient's status is due to active myeloma
- •All patients must be informed of the investigational nature of the study and have signed an IRB-approved informed consent in accordance with institutional and federal guidelines.
排除标准
- •Serum transaminases > 1.5 x ULN and direct bilirubin > 1.5 mg/dl
- •HIV positive or active Hepatitis B or Hepatitis C infection; (if serology is positive a quantitative PCR will be done).
- •Patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. Patients must not currently be receiving therapy for the prior malignancy.
- •Pregnant or nursing women. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
研究组 & 干预措施
Busulfan
study-specific treatment: Busulfex according to study design: Level I 3.2 mg/kg over 6 hours x 2 days Level II 3.2 mg/kg over 6 hours x 3 days Level III 3.2 mg/kg over 6 hours x 4 days Level IV 4.3 mg/kg over 6 hours x 3 days Level V 5.6 mg/kg over 6 hours x 2 days Level VI 6.4 mg/kg over 6 hours x 2 days
干预措施: Busulfan (Drug)
结局指标
主要结局
Maximal Dose of Busulfex® Given in a 2, 3, or 4 Day Period With Acceptable Toxicity to Myeloma Patients
时间窗: three years
maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min
次要结局
未报告次要终点