Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-24 @ 6:46 PM
NCT ID:
NCT03767257
Eligibility Criteria:
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03767257
Study Brief:
Protocol Section:
NCT03767257