A Placebo Controlled Study to Estimate the Effect Size of Glutamine as a Supplement to Prevent Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Degree of Peripheral Neuropathy (PNP)
研究概览
简要总结
This randomized phase II trial studies glutamine in preventing peripheral neuropathy in patients with multiple myeloma who are receiving bortezomib. Glutamine may help prevent peripheral neuropathy in patients receiving chemotherapy
详细描述
PRIMARY OBJECTIVES:
I. Estimate the objective effect size of glutamine compared to placebo as a prophylactic intervention to prevent bortezomib-induced peripheral neuropathy in multiple myeloma patients 4 months after their first dose of study drug.
SECONDARY OBJECTIVES:
I. Estimate whether glutamine delays or prevents the onset or worsening of any neuropathy as determined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
II. Determine if glutamine may improve adherence to bortezomib therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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 with a diagnosis of multiple myeloma who received bortezomib at a dose of 1.3mg/m2 SQ weekly
- •No evidence of severe pre-existing peripheral neuropathy, NCI-CTCAE v4.03 =< 2
- •Performance status =< 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
排除标准
- •Concurrent use of thalidomide, vincristine, platinum compound, or other agent known to cause significant neuropathy (concurrent lenalidomide will be allowed)
- •Hospitalization with clinical evidence of active infections as manifested by recurrent fevers, positive blood culture results, or requiring intravenous antibiotic therapy
- •Inadequate liver and renal function with liver transaminases 3x the upper limit of normal
- •Glomerular filtration rate (GFR) according to Cockcroft-Gault < 30 mL/min
- •Uncontrolled congestive heart failure
- •Uncontrolled mood disorders
- •Fasting blood glucose >150mg/dL or blood sugar (non-fasting) >200mg/dL if no history of diabetes. Uncontrolled diabetes with HgA1C greater 7% with last evaluation.
- •Seizure disorder
- •Monosodium glutamate (MSG) allergy or soy allergy
- •Life expectancy of shorter than 3 months based on clinical laboratory parameters and the investigator's opinion
- •Uncorrected Vitamin B12 or folate deficiency on last evaluation.
- •Use of over the counter (OTC) supplements other than one multivitamin tablet a day
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Arm I (preventative nutritional supplementation)
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
干预措施: glutamine (Drug)
Arm I (preventative nutritional supplementation)
Patients receive glutamine PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID. Courses repeat every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
干预措施: placebo (Other)
结局指标
主要结局
Degree of Peripheral Neuropathy (PNP)
时间窗: up to 4 months from start of study
The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.
次要结局
- RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])(up to 4 months from start of study)
- Adherence to Bortezomib Treatment(Up to 4 months)
- Average Change in Quality of Life Scores From Baseline to End of Study(from baseline to end of study at 4 months)
研究者
Beth Faiman
Principal Investigator
Case Comprehensive Cancer Center