A Study of Colesevelam for Lenalidomide-Associated Diarrhea

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Diarrhea

Treatments

Drug: Colesevelam Pill

Study type

Interventional

Funder types

Other

Identifiers

NCT03767257

18-421

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)