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

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Antiemetics; Aprepitant; Emetics; Fosaprepitant; Melphalan; Olanzapine

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)