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

Sponsor

Rush University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02939287

Collaborator

(none)

429

Enrollment

Location

Arms

37.3

Anticipated Duration (Months)

11.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting	Drug: Aprepitant Drug: Olanzapine Drug: Aprepitant plus Olanzapine	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

429 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Aprepitant- and Olanzapine- Containing Regimens for Prevention of Acute and Delayed Nausea and Vomiting Associated With High Dose Melphalan and BEAM in Autologous Stem Cell Transplant Patients

Actual Study Start Date :

Sep 23, 2017

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aprepitant aprepitant plus standard anti-emetic regimen	Drug: Aprepitant Add aprepitant to anti-emetic regimen Other Names: Emend
Experimental: Olanzapine olanzapine plus standard anti-emetic regimen	Drug: Olanzapine add olanzapine to anti-emetic regimen Other Names: Zyprexa
Experimental: Aprepitant plus olanzapine aprepitant and olanzapine plus standard anti-emetic regimen	Drug: Aprepitant plus Olanzapine add aprepitant and olanzapine to anti-emetic regimen Other Names: Emend Zyprexa

Arm

Intervention/Treatment

Active Comparator: Aprepitant

aprepitant plus standard anti-emetic regimen

Drug: Aprepitant

Add aprepitant to anti-emetic regimen

Other Names:

Emend

Experimental: Olanzapine

olanzapine plus standard anti-emetic regimen

Drug: Olanzapine

add olanzapine to anti-emetic regimen

Other Names:

Zyprexa

Experimental: Aprepitant plus olanzapine

aprepitant and olanzapine plus standard anti-emetic regimen

Drug: Aprepitant plus Olanzapine

add aprepitant and olanzapine to anti-emetic regimen

Other Names:

Emend

Zyprexa

Outcome Measures

Primary Outcome Measures

complete response (CR) [within 120 hours following melphalan administration]
no emesis and no rescue anti-emetic therapy

Secondary Outcome Measures

Acute complete response [0 to 24 hours]
no emesis or rescue therapy
Delayed complete response [25-120 hours]
no emesis or rescue therapy
Very delayed complete response [121-168 hours]
no emesis or rescue therapy
Mucositis/Significant mucositis [up to 14 days]
Time to neutrophil engraftment [up to 14 days]
Time to platelet engraftment [up to 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)