A Study of Colesevelam for Lenalidomide… | Clinical Trial

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Diarrhea Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Colesevelam Pill

Drug

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.

Primary outcomes

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

Time frame: 4 weeks

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.

Secondary outcomes

Number of Participants With GI Symptom Assessment

Time frame: 4 weeks

To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Dec 6, 2018
Registry last updated: Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed