Diarrhea, Multiple Myeloma
Conditions
Keywords
Lenalidomide Associated Diarrhea, Colesevelam, 18-421, 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.
Interventions
DRUGColesevelam 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Myeloma Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Participants With Myeloma |
|---|---|
| Age, Continuous | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 25 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Participants With 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.
Time frame: 4 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Myeloma | 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 |
| Participants With Myeloma | Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0 | Did not respond to colesevelam treatment | 3 Participants |
Secondary
Number of Participants With GI Symptom Assessment
To assess GI symptoms using Patient Reported Outcomes within the Common Terminology Criteria for Adverse Events
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Myeloma | Number of Participants With GI Symptom Assessment | 25 Participants |