Trial Outcomes & Findings for Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan (NCT NCT02939287)
NCT ID: NCT02939287
Last Updated: 2024-10-22
Results Overview
no emesis and no rescue anti-emetic therapy
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
within 120 hours following melphalan administration; no emesis and no rescue therapy within 120 hours of melphalan administration (within 120 hours following last day of melphalan administration at baseline)
Results posted on
2024-10-22
Participant Flow
Participant milestones
| Measure |
Aprepitant
aprepitant plus standard anti-emetic regimen
Aprepitant: Add aprepitant to anti-emetic regimen
|
Olanzapine
olanzapine plus standard anti-emetic regimen
Olanzapine: add olanzapine to anti-emetic regimen
|
Aprepitant Plus Olanzapine
aprepitant and olanzapine plus standard anti-emetic regimen
Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
25
|
9
|
|
Overall Study
COMPLETED
|
14
|
21
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
Reasons for withdrawal
| Measure |
Aprepitant
aprepitant plus standard anti-emetic regimen
Aprepitant: Add aprepitant to anti-emetic regimen
|
Olanzapine
olanzapine plus standard anti-emetic regimen
Olanzapine: add olanzapine to anti-emetic regimen
|
Aprepitant Plus Olanzapine
aprepitant and olanzapine plus standard anti-emetic regimen
Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
|
|---|---|---|---|
|
Overall Study
met exclusion criteria
|
1
|
1
|
1
|
|
Overall Study
Did not complete survey
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
Baseline characteristics by cohort
| Measure |
Aprepitant
n=14 Participants
aprepitant plus standard anti-emetic regimen
Aprepitant: Add aprepitant to anti-emetic regimen
|
Olanzapine
n=21 Participants
olanzapine plus standard anti-emetic regimen
Olanzapine: add olanzapine to anti-emetic regimen
|
Aprepitant Plus Olanzapine
n=8 Participants
aprepitant and olanzapine plus standard anti-emetic regimen
Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=5 Participants
|
61 years
n=7 Participants
|
54 years
n=5 Participants
|
57.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
6 participants
n=5 Participants
|
15 participants
n=7 Participants
|
3 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
21 participants
n=7 Participants
|
8 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Conditioning Chemotherapy Regimen
BEAM
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Conditioning Chemotherapy Regimen
1-day melphalan
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
6 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Conditioning Chemotherapy Regimen
2-day melphalan
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 120 hours following melphalan administration; no emesis and no rescue therapy within 120 hours of melphalan administration (within 120 hours following last day of melphalan administration at baseline)no emesis and no rescue anti-emetic therapy
Outcome measures
| Measure |
Aprepitant
n=14 Participants
aprepitant plus standard anti-emetic regimen
Aprepitant: Add aprepitant to anti-emetic regimen
|
Olanzapine
n=21 Participants
olanzapine plus standard anti-emetic regimen
Olanzapine: add olanzapine to anti-emetic regimen
|
Aprepitant Plus Olanzapine
n=8 Participants
aprepitant and olanzapine plus standard anti-emetic regimen
Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
|
|---|---|---|---|
|
Complete Response (CR)
|
4 Participants
|
11 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 (transplant time) to 24 hours post-transplantPopulation: No data were collected or analyzed for this outcome.
no emesis or rescue therapy; Acute complete response defined as no emesis or rescue therapy required from time point of 0 to 24 hours following melphalan therapy administration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 25-120 hours post-transplantPopulation: No data were collected or analyzed for this outcome.
no emesis or rescue therapy administered; Delayed complete response defined as no emesis or rescue therapy required from time point of 25 hours to 120 hours following melphalan therapy administration
Outcome measures
Outcome data not reported
Adverse Events
Aprepitant
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Olanzapine
Serious events: 3 serious events
Other events: 0 other events
Deaths: 21 deaths
Aprepitant Plus Olanzapine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aprepitant
n=14 participants at risk
aprepitant plus standard anti-emetic regimen
Aprepitant: Add aprepitant to anti-emetic regimen
|
Olanzapine
n=21 participants at risk
olanzapine plus standard anti-emetic regimen
Olanzapine: add olanzapine to anti-emetic regimen
|
Aprepitant Plus Olanzapine
n=8 participants at risk
aprepitant and olanzapine plus standard anti-emetic regimen
Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
|
|---|---|---|---|
|
Gastrointestinal disorders
Mucositis
|
21.4%
3/14 • Patients were monitored for 3 years.
|
14.3%
3/21 • Patients were monitored for 3 years.
|
12.5%
1/8 • Patients were monitored for 3 years.
|
Other adverse events
Adverse event data not reported
Additional Information
Danielle Murphy, PharmD, BCOP, BCPS
Rush University Medical Center
Phone: 3129472401
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place