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Bile Acid Sequestrant

Colesevelam for Lenalidomide-Associated Diarrhea in Multiple Myeloma

Phase 2
Waitlist Available
Led By Malin Hultcrantz, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Treatment with single agent lenalidomide maintenance
Must not have
Patients currently already receiving a bile acid sequestrant or have previously used bile acid sequestrant drugs for diarrhea and had no benefit
Patients with history of bowel obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing colesevelam, a drug usually used to lower cholesterol, to see if it can help reduce diarrhea in multiple myeloma patients taking lenalidomide. These patients often experience diarrhea as a side effect of their treatment. Colesevelam works by attaching to substances in the gut, which can help firm up stools and reduce diarrhea.

Who is the study for?
This trial is for adults over 18 with multiple myeloma on lenalidomide maintenance who are experiencing mild to severe diarrhea. They must be able to follow the study plan and get treatment at Memorial Sloan Kettering Cancer Center. People can't join if they're allergic to colesevelam, have used bile acid sequestrants without relief, have bowel obstruction, very high triglycerides or a history of related pancreatitis, or diarrhea from an infection.
What is being tested?
The trial is testing the safety and effect of colesevelam pills on controlling diarrhea caused by lenalidomide in multiple myeloma patients. It aims to see how well colesevelam manages this side effect during their maintenance therapy.
What are the potential side effects?
Colesevelam may cause side effects such as constipation, indigestion, nausea, increased triglycerides levels and possible hypersensitivity reactions in those allergic to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had diarrhea for at least 4 days in the past week.
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I am currently on lenalidomide maintenance therapy alone.
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I am 18 years old or older.
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I am scheduled for lenalidomide treatment at MSK.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used bile acid drugs for diarrhea without any improvement.
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I have had a blockage in my intestines before.
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I have had pancreatitis caused by high triglyceride levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0
Secondary study objectives
GI symptom assessment

Side effects data

From 2010 Phase 4 trial • 42 Patients • NCT01122108
5%
Gas
5%
Diarrhea
5%
Mild Indigestion
2%
Bloating
2%
Increased Urination
2%
Abdominal Cramps
2%
Belching
2%
Intermittent R Back Thigh Pain
2%
Moderate Indigestion
2%
Severe Indigestion
2%
Headache
2%
Moderate Nausea
2%
Vomitting
100%
80%
60%
40%
20%
0%
Study treatment Arm
More Than 30 Minutes After Last Beverage
Cholestyramine (12g)
Colesevelam HCl (3.75 Grams)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with MyelomaExperimental Treatment1 Intervention
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bile acid sequestrants, such as colesevelam and cholestyramine, work by binding bile acids in the gut, preventing their reabsorption and thereby reducing diarrhea caused by excess bile acids. This is particularly important for patients with conditions like bile acid diarrhea or those who have undergone ileal resection, where bile acid malabsorption is common. By reducing the bile acid concentration in the colon, these agents help to decrease water and electrolyte loss, improving stool consistency and reducing the frequency of diarrhea. This mechanism is crucial for managing symptoms and improving the quality of life for patients suffering from chronic diarrhea related to bile acid malabsorption.
Double-blind trial of cholestyramine in post-vagotomy diarrhoea.Oral cholestyramine and paregoric therapy for intractable diarrhea following surgical correction of catastrophic disease of the GI tract in neonates.Bile acids in the diarrhoea of ileal resection.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,226 Total Patients Enrolled
1 Trials studying Diarrhea
4 Patients Enrolled for Diarrhea
Malin Hultcrantz, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

Colesevelam (Bile Acid Sequestrant) Clinical Trial Eligibility Overview. Trial Name: NCT03767257 — Phase 2
Diarrhea Research Study Groups: Participants with Myeloma
Diarrhea Clinical Trial 2023: Colesevelam Highlights & Side Effects. Trial Name: NCT03767257 — Phase 2
Colesevelam (Bile Acid Sequestrant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767257 — Phase 2
~2 spots leftby Jun 2025