A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
研究概览
简要总结
The purpose of this study is to test the safety of colesevelam and find out what effects, if any, colesevelam has on lenalidomide associated diarrhea in participants with multiple myeloma on lenalidomide maintenance.
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
- •Memorial Sloan Kettering Cancer Center (MSK) confirmed diagnosis of multiple myeloma
- •Treatment with single agent lenalidomide maintenance
- •Patient must be >/= 18 years of age at the time of informed consent
- •Experiencing grade 1 or more diarrhea according to the CTCAE 5.0 criteria for at least 4 out of 7 days preceding screening and study inclusion
- •Scheduled to receive lenalidomide maintenance cyles at MSK
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
排除标准
- •Patients with history of bowel obstruction
- •Patients with serum triglyceride levels >300 mg/dL
- •Patients wit history of hypertriglyceridemia-induced panreatitis
- •Patients with known hypersensitivity to colesevelam or any component to the formulation
- •Patients currently already receiving a bile acid sequestrant or have previously used bile acid sequestrant drugs for diarrhea and had no benefit
- •Patients with diarrhea secondary to infection. Stool studies for GI pathogens should be collected prior to starting colesevelam but do not need to be resulted prior to starting Day 1 dose of colesevelam, unless infection is suspected by the treating investigator, in which case (Clostridium difficile PCR when clinically indicated, GI pathogen panel, stool ova and parasites, Giardia and Cryptosporum stool antigen tests will need to be resulted at investigator discretion.)
研究组 & 干预措施
Participants with Myeloma
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
干预措施: Colesevelam Pill (Drug)
结局指标
主要结局
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
时间窗: 4 weeks
To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam.
次要结局
- Number of Participants With GI Symptom Assessment(4 weeks)