A Study of Colesevelam for Lenalidomide-Associated Diarrhea

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea

Conditions
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Multiple Myeloma, Diarrhea

Intervention / Treatment
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* Drug: Colesevelam Pill


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Myeloma<br>Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea | Drug: Colesevelam Pill<br>* For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0 | To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI symptom assessment | To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenalidomide Associated Diarrhea, Colesevelam, 18-421, Memorial Sloan Kettering Cancer Center