Trial Outcomes & Findings for A Study of Colesevelam for Lenalidomide-Associated Diarrhea (NCT NCT03767257)
NCT ID: NCT03767257
Last Updated: 2025-10-21
Results Overview
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.
COMPLETED
PHASE2
25 participants
4 weeks
2025-10-21
Participant Flow
Participant milestones
| Measure |
Participants With Myeloma
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
Baseline characteristics by cohort
| Measure |
Participants With Myeloma
n=25 Participants
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeksTo 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.
Outcome measures
| Measure |
Participants With Myeloma
n=25 Participants
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
|---|---|
|
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
Improvement by at least 1 grade per CTCAE scale
|
22 Participants
|
|
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
Did not respond to colesevelam treatment
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 weeksTo assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
Outcome measures
| Measure |
Participants With Myeloma
n=25 Participants
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
|---|---|
|
Number of Participants With GI Symptom Assessment
|
25 Participants
|
Adverse Events
Participants With Myeloma
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Myeloma
n=25 participants at risk
Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
25/25 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • 4 weeks
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • 4 weeks
|
|
Gastrointestinal disorders
Acid reflux
|
4.0%
1/25 • 4 weeks
|
|
Infections and infestations
Shingles
|
4.0%
1/25 • 4 weeks
|
|
Infections and infestations
Sars-CoV-2
|
8.0%
2/25 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • 4 weeks
|
Additional Information
Dr. Malin Hultcrantz, MD, PhD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place