NCT02939287 · REGISTRY CONDITION SEARCH

Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2024-10-22

The purpose of this study is to help answer the following research question: * Whether administration of an aprepitant containing regimen, an olanzapine containing regimen or regimen containing both will prevent nausea and vomiting better for patients undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these medications are approved by the United States Food and Drug Administration (FDA) for nausea and vomiting. * Participants will be randomly assigned to one of the 3 treatment groups: * Arm A: aprepitant containing anti-emetic therapy * Arm B: olanzapine containing anti-emetic therapy * Arm C: Aprepitant plus olanzapine containing anti-emetic therapy

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Response (CR)

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outcome · POSTED

Acute Complete Response

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outcome · POSTED

Delayed Complete Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Autologous transplant containing high dose melphalan as part of the conditioning regimen (single or 2 day melphalan; BEAM \[carmustine, etoposide, cytarabine, melphalan\]) * able to tolerate oral medications Exclusion Criteria: * Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy * Any anti-emetic treatment within 24 hours before planned high dose conditioning chemotherapy * Pregnancy * Baseline corrected QT interval (QTc) \> 500 ms * History of seizures * History of central nervous system (CNS) disease * Human immunodeficiency virus (HIV)
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
aprepitant plus standard anti-emetic regimen
intervention Names
Drug: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1
label
Aprepitant
type
ACTIVE_COMPARATOR
description
olanzapine plus standard anti-emetic regimen
intervention Names
Drug: Olanzapine10 mg orally daily on Days -1,0,+1 and +2
label
Olanzapine
type
EXPERIMENTAL
description
aprepitant and olanzapine plus standard anti-emetic regimen
intervention Names
Drug: Aprepitant plus Olanzapine
label
Aprepitant plus olanzapine
type
EXPERIMENTAL

interventions

arm Group Labels
Aprepitant
description
Add aprepitant to anti-emetic regimen
name
o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1
other Names
Emend
type
DRUG
arm Group Labels
Olanzapine
description
add olanzapine to anti-emetic regimen
name
Olanzapine10 mg orally daily on Days -1,0,+1 and +2
other Names
Zyprexa
type
DRUG
arm Group Labels
Aprepitant plus olanzapine
description
add aprepitant and olanzapine to anti-emetic regimen
name
Aprepitant plus Olanzapine
other Names
Emend
Zyprexa
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 52
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
no emesis and no rescue anti-emetic therapy
measure
Complete Response (CR)
time Frame
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)

secondary Outcomes

description
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
measure
Acute Complete Response
time Frame
0 (transplant time) to 24 hours post-transplant
description
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
measure
Delayed Complete Response
time Frame
25-120 hours post-transplant

Full study description

brief Summary: The purpose of this study is to help answer the following research question: * Whether administration of an aprepitant containing regimen, an olanzapine containing regimen or regimen containing both will prevent nausea and vomiting better for patients undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these medications are approved by the United States Food and Drug Administration (FDA) for nausea and vomiting. * Participants will be randomly assigned to one of the 3 treatment groups: * Arm A: aprepitant containing anti-emetic therapy * Arm B: olanzapine containing anti-emetic therapy * Arm C: Aprepitant plus olanzapine containing anti-emetic therapy
detailed Description: This is a multi-center, randomized, non-inferiority phase 3 study conducted to determine an appropriate anti-emetic regimen for patients receiving melphalan for an autologous stem cell transplant (SCT). Candidates for this trial will include patients aged 18-80 years with hematologic malignancies receiving high dose melphalan as part of a conditioning regimen for an autologous stem cell transplant. Patients will be enrolled in 3 arms. Patients in Arm A will receive an aprepitant containing anti-emetic regimen. Patients in Arm B will receive an olanzapine containing anti-emetic regimen. Patients in Arm C will receive an aprepitant plus olanzapine containing anti-emetic regimen. Patients must be able to tolerate oral medications. Patients will be carefully monitored for rates of emesis, nausea, and mucositis. Any adverse events will be recorded. Impact on quality of life will also be assessed. A total of 184 patients will be accrued to each arm. It is anticipated that the accrual period will last approximately 2-3 years. The primary endpoint of this study is a complete response, defined as no emesis and no rescue therapy within 120 hours of melphalan administration.

Source references

references

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