A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Primary Purpose
Multiple Myeloma, Diarrhea
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colesevelam Pill
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Lenalidomide Associated Diarrhea, Colesevelam, 18-421, Memorial Sloan Kettering Cancer Center
Eligibility 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 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.)
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
- Memorial Sloan Kettering Bergen
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities)
- Memorial Sloan Kettering Westchester (All Protocol Activities)
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Nassau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with Myeloma
Arm Description
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
Outcomes
Primary Outcome Measures
Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0
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
GI symptom assessment
To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
Full Information
NCT ID
NCT03767257
First Posted
December 5, 2018
Last Updated
June 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03767257
Brief Title
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Official Title
A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Diarrhea
Keywords
Lenalidomide Associated Diarrhea, Colesevelam, 18-421, Memorial Sloan Kettering Cancer Center
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with Myeloma
Arm Type
Experimental
Arm Description
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
Intervention Type
Drug
Intervention Name(s)
Colesevelam Pill
Intervention Description
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 Measure Information:
Title
Improvement of lenalidomide-associated diarrhea evaluated by CTCAE 5.0
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
GI symptom assessment
Description
To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Hultcrantz, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
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