Clinical trial · Interventional
A Study of Colesevelam for Lenalidomide-Associated Diarrhea
A Phase 2 Study of Colesevelam for Lenalidomide-Associated Diarrhea
NCT03767257CI-TRIAL-00096695completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diarrhea | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colesevelam Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Myeloma
- description
- Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
- interventionNames
- Drug: Colesevelam Pill
Primary outcomes (1)
- measure
- Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
- timeFrame
- 4 weeks
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.