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

Rush

Status and phase: Completed; Phase 3

Conditions: Vomiting; Nausea

Treatments: Drug: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1; Drug: Aprepitant plus Olanzapine; Drug: Olanzapine10 mg orally daily on Days -1,0,+1 and +2

Study type: Interventional

Funder types: Other

Identifiers

NCT02939287

14102001

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 3 patient groups

Aprepitant

Active Comparator group

Description:

aprepitant plus standard anti-emetic regimen

Treatment:

Drug: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1

Olanzapine

Experimental group

Description:

olanzapine plus standard anti-emetic regimen

Treatment:

Drug: Olanzapine10 mg orally daily on Days -1,0,+1 and +2

Aprepitant plus olanzapine

Experimental group

Description:

aprepitant and olanzapine plus standard anti-emetic regimen

Treatment:

Drug: Aprepitant plus Olanzapine