A Study of Colesevelam for Lenalidomide-Associated Diarrhea
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
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.
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. Infections will need to be ruled out
 (Clostridium difficile PCR when clinically indicated, GI pathogen panel, stool ova and
 parasites, Giardia and Cryptosporum stool antigen tests) prior to starting treatment
 in all patients.