NCT03767257 · REGISTRY CONDITION SEARCH

A Study of Colesevelam for Lenalidomide-Associated Diarrhea

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-10-21

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0

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outcome · POSTED

Number of Participants With GI Symptom Assessment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
intervention Names
Drug: Colesevelam Pill
label
Participants with Myeloma
type
EXPERIMENTAL

interventions

arm Group Labels
Participants with Myeloma
description
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.
name
Colesevelam Pill
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
time Frame
4 weeks

secondary Outcomes

description
To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
measure
Number of Participants With GI Symptom Assessment
time Frame
4 weeks

Full study description

brief 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.

Source references