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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will test if colesevelam is safe for patients with multiple myeloma who experience diarrhea while taking lenalidomide.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0

Secondary outcome measures

GI symptom assessment

Side effects data

From 2010 Phase 4 trial • 42 Patients • NCT01122108

Gas

Diarrhea

Mild Indigestion

Bloating

Increased Urination

Abdominal Cramps

Belching

Intermittent R Back Thigh Pain

Moderate Indigestion

Severe Indigestion

Headache

Moderate Nausea

Vomitting

100%

80%

60%

40%

20%

Study treatment Arm

More Than 30 Minutes After Last Beverage

Cholestyramine (12g)

Colesevelam HCl (3.75 Grams)

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,597 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

48 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide a survey of the research done on Colesevelam Pill?

"Colesevelam Pill was first tested in 2018 at Memorial Sloan Kettering Bergen. To date, 39 studies have been concluded and there is currently one ongoing clinical trial being run from Basking Ridge, New york."

Answered by AI

Are recruitments still taking place for this research project?

"As per the clinicaltrials.gov listing, this experiment is not presently enrolling patients; it was initially posted on December 3rd 2018 and its latest update came on August 24th 2022. Although recruitment for this trial has ceased, there are 876 other trials that require participants right now."

Answered by AI

In what regions is this clinical experimentation taking place?

"The trial is actively enrolling participants and has 7 different sites situated in Basking Ridge, Uniondale, New york City and other cities. To reduce travel requirements for those partaking, it's best to choose a medical centre nearby."

Answered by AI

What governmental agencies have sanctioned Colesevelam Pill for public use?

"Our team's assessment of the safety of Colesevelam Pill is 2, as this Phase 2 trial has provided evidence to bolster its security but not yet proven efficacy."

Answered by AI

What is the current patient census involved in this clinical investigation?

"This clinical trial has ceased recruitment; it was first posted on December 3rd 2018 and its latest update occurred August 24th 2022. Should you seek other studies, 875 trials concerning diarrhea are currently enrolling patients while one study is researching Colesevelam Pill."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Colesevelam for Lenalidomide-Associated Diarrhea

2018. "A Study of Colesevelam for Lenalidomide-Associated Diarrhea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03767257.

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