A Study of Colesevelam for Lenalidomide-Associated Diarrhea
- Registration Number
- NCT03767257
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with Myeloma Colesevelam Pill Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
- Primary Outcome Measures
Name Time Method Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0 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.
- Secondary Outcome Measures
Name Time Method GI symptom assessment 4 weeks To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
Trial Locations
- Locations (7)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities)
🇺🇸Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Nassau
🇺🇸Uniondale, New York, United States