Trial Outcomes & Findings for Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT (NCT NCT02619812)
NCT ID: NCT02619812
Last Updated: 2017-06-14
Results Overview
Stool frequency was self reported in a daily bowel pattern diary for 30 days.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
30 days
Results posted on
2017-06-14
Participant Flow
The subjects were recruited from Mayo Clinic in Rochester, Minnesota.
A total of 4 subjects were enrolled. Two subjects were randomized to placebo/placebo, and one subject was randomized to colesevelam/Serum-derived bovine immunoglobulin/protein isolate (SBI). One subject was consented, but never randomized/accrued.
Participant milestones
| Measure |
Group A: SBI + Placebo
SBI 10 grams + placebo twice per day.
|
Group B: Colesevelam + Placebo
Colesevelam 1.875 g + Placebo twice per day
|
Group C: Colesevelam + SBI
Colesevelam 1.875 g + SBI 10 grams twice per day.
|
Group D: Double Placebo
Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group A: SBI + Placebo
SBI 10 grams + placebo twice per day.
|
Group B: Colesevelam + Placebo
Colesevelam 1.875 g + Placebo twice per day
|
Group C: Colesevelam + SBI
Colesevelam 1.875 g + SBI 10 grams twice per day.
|
Group D: Double Placebo
Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT
Baseline characteristics by cohort
| Measure |
Group A: SBI + Placebo
SBI 10 grams + placebo twice per day.
|
Group B: Colesevelam + Placebo
Colesevelam 1.875 g + Placebo twice per day
|
Group C: Colesevelam + SBI
n=1 Participants
Colesevelam 1.875 g + SBI 10 grams twice per day.
|
Group D: Double Placebo
n=2 Participants
Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Data were not collected.
Stool frequency was self reported in a daily bowel pattern diary for 30 days.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 daysPopulation: Data were not collected.
The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.
Outcome measures
Outcome data not reported
Adverse Events
Group A: SBI + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Colesevelam + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C: Colesevelam + SBI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group D: Double Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: SBI + Placebo
SBI 10 grams + placebo twice per day.
|
Group B: Colesevelam + Placebo
Colesevelam 1.875 g + Placebo twice per day
|
Group C: Colesevelam + SBI
n=1 participants at risk
Colesevelam 1.875 g + SBI 10 grams twice per day.
|
Group D: Double Placebo
n=2 participants at risk
Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
100.0%
2/2 • Number of events 2 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
50.0%
1/2 • Number of events 1 • 30 days
|
|
General disorders
Fatigue
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
50.0%
1/2 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Stomach cramps
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
50.0%
1/2 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
50.0%
1/2 • Number of events 1 • 30 days
|
|
Reproductive system and breast disorders
Testicular pain
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
0.00%
0/1 • 30 days
|
50.0%
1/2 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
Abdominal bloating
|
—
0/0 • 30 days
|
—
0/0 • 30 days
|
100.0%
1/1 • Number of events 1 • 30 days
|
0.00%
0/2 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place