A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Completed · Phase 2
Conditions studied: Multiple Myeloma, Diarrhea
In brief
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.
Key facts
- Study ID
- NCT03767257
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 25
- Starts
- 2018-12-03
- Expected to finish
- 2024-11-27
- Last updated by the study team
- 2025-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.)
Where it is running
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, 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 Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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