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A Study of Colesevelam for Lenalidomide-Associated Diarrhea

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ClinicalTrials.gov Identifier: NCT03767257
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Diarrhea Drug: Colesevelam Pill Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Participants with Myeloma
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
Drug: Colesevelam Pill
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 Outcome Measures :
  1. 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 Outcome Measures :
  1. GI symptom assessment [ Time Frame: 4 weeks ]
    To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767257


Contacts
Contact: Malin Hultcrantz, MD, PhD 212-639-7986 hultcram@mskcc.org
Contact: Ola Landgren, MD, PhD 212-639-5126 landgrec@mskcc.org

Locations
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Memorial Sloan Kettering @ Rockville Recruiting
Rockville Centre, New York, United States, 11570
Contact: Malin Hultcrantz, MD, PhD    212-639-7986      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Malin Hultcrantz, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03767257     History of Changes
Other Study ID Numbers: 18-421
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Lenalidomide Associated Diarrhea
Colesevelam
18-421
Memorial Sloan Kettering Cancer Center

Additional relevant MeSH terms:
Multiple Myeloma
Diarrhea
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Lenalidomide
Thalidomide
Colesevelam Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents