A Study of Colesevelam for Lenalidomide-Associated Diarrhea



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Blood Cancer, Gastrointestinal, Hematology
Therapuetic Areas:Gastroenterology, Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:December 3, 2018
End Date:June 2020
Contact:Malin Hultcrantz, MD, PhD
Email:hultcram@mskcc.org
Phone:212-639-7986

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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.


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 2 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. Infections will need to be ruled out
(Clostridium difficile PCR when clinically indicated, GI pathogen panel, stool ova and
parasites, Giardia and Cryptosporum stool antigen tests) prior to starting treatment
in all patients.
We found this trial at
8
sites
Harrison, New York
Phone: 212-639-7986
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Basking Ridge, New Jersey 07920
Phone: 212-639-7986
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650 Commack Rd
Commack, New York 11725
(631) 623-4000
Phone: 212-639-7986
Memorial Sloan-Kettering Cancer Center at Commack Memorial Sloan Kettering Cancer Center - the world's oldest...
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Commack, NY
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 212-639-7986
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-7986
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Montvale, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-7986
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1000 North Village Avenue
Rockville Centre, New York 11570
Phone: 212-639-7986
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Rockville Centre, NY
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Uniondale, New York 11553
Phone: 212-639-7986
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Uniondale, NY
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