Status:
COMPLETED
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Multiple Myeloma
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lenalidom...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03767257
Start Date
December 3 2018
End Date
November 27 2024
Last Update
October 21 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725