Trial · NCT03767257
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
NCT03767257, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2025-10-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Colesevelam for Lenalidomide-Associated Diarrhea. Trials, record NCT03767257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03767257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Colesevelam for Lenalidomide-Associated Diarrhea
- NCT number
- NCT03767257
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Multiple Myeloma, Diarrhea
- Interventions
- Colesevelam Pill
- First posted
- 2018-12-06
- Last updated
- 2025-10-21
- Results first posted
- 2025-10-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0 | 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 | Number of Participants With GI Symptom Assessment | 4 weeks | To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0 | 4 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With GI Symptom Assessment | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0 | Participants With Myeloma | 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 | Participants With Myeloma | Did not respond to colesevelam treatment | 3 | Participants | |
| Number of Participants With GI Symptom Assessment | Participants With Myeloma | 25 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Myeloma | 25 | |
| Overall Study | COMPLETED | Participants With Myeloma | 25 | |
| Overall Study | NOT COMPLETED | Participants With Myeloma | 0 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Participants With Myeloma | 25 | 25 | |
| other | Constipation | Gastrointestinal disorders | Participants With Myeloma | 3 | 25 | |
| other | Flatulence | Gastrointestinal disorders | Participants With Myeloma | 1 | 25 | |
| other | Acid reflux | Gastrointestinal disorders | Participants With Myeloma | 1 | 25 | |
| other | Shingles | Infections and infestations | Participants With Myeloma | 1 | 25 | |
| other | Sars-CoV-2 | Infections and infestations | Participants With Myeloma | 2 | 25 | |
| other | Nausea | Gastrointestinal disorders | Participants With Myeloma | 5 | 25 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Myeloma | 0 | 25 |
| Total, other adverse events | Participants With Myeloma | 25 | 25 |
| Total, serious adverse events | Participants With Myeloma | 0 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03767257
GET https://conductscience.org/api/trials/v1/NCT03767257/registered