A Study of Colesevelam for Lenalidomide-Associated Diarrhea (NCT03767257) | Clinical Trial Compass
CompletedPhase 2
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
United States25 participantsStarted 2018-12-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0