- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767257
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
June 29, 2023 updated by: Memorial Sloan Kettering Cancer Center
A Phase 2 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (All protocol activities)
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
-
-
New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with Myeloma
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GI symptom assessment
Time Frame: 4 weeks
|
To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Malin Hultcrantz, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2018
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
December 5, 2018
First Submitted That Met QC Criteria
December 5, 2018
First Posted (Actual)
December 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Signs and Symptoms, Digestive
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
- Diarrhea
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Colesevelam Hydrochloride
Other Study ID Numbers
- 18-421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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