Clinical trial · Interventional
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea | — | UNRESOLVED | — |
| Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant plus Olanzapine | Drug | — | UNRESOLVED |
| o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1 | Drug | — | UNRESOLVED |
| Olanzapine10 mg orally daily on Days -1,0,+1 and +2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Aprepitant
- description
- aprepitant plus standard anti-emetic regimen
- interventionNames
- Drug: o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1
- type
- EXPERIMENTAL
- label
- Olanzapine
- description
- olanzapine plus standard anti-emetic regimen
- interventionNames
- Drug: Olanzapine10 mg orally daily on Days -1,0,+1 and +2
- type
- EXPERIMENTAL
- label
- Aprepitant plus olanzapine
- description
- aprepitant and olanzapine plus standard anti-emetic regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (14)
- BACKGROUNDBasch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR, Chesney M, Clark-Snow RA, Flaherty AM, Freundlich B, Morrow G, Rao KV, Schwartz RN, Lyman GH; American Society of Clinical Oncology. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011 Nov 1;29(31):4189-98. doi: 10.1200/JCO.2010.34.4614. Epub 2011 Sep 26. PMID 21947834
- BACKGROUNDNavari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24. PMID 22024310
- BACKGROUNDGiralt SA, Mangan KF, Maziarz RT, Bubalo JS, Beveridge R, Hurd DD, Mendoza FL, Rubenstein EB, DeGroot TJ, Schuster MW. Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. Ann Oncol. 2011 Apr;22(4):939-946. doi: 10.1093/annonc/mdq457. Epub 2010 Oct 8. PMID 20935058
- BACKGROUNDSlaby J, Trneny M, Prochazka B, Klener P. Antiemetic efficacy of three serotonin antagonists during high-dose chemotherapy and autologous stem cell transplantation in malignant lymphoma. Neoplasma. 2000;47(5):319-22. PMID 11130251
- BACKGROUNDBallen KK, Hesketh AM, Heyes C, Becker PS, Emmons RV, Fogarty K, LaPointe J, Liu Q, Hsieh CC, Hesketh PJ. Prospective evaluation of antiemetic outcome following high-dose chemotherapy with hematopoietic stem cell support. Bone Marrow Transplant. 2001 Dec;28(11):1061-6. doi: 10.1038/sj.bmt.1703280. PMID 11781617
- BACKGROUNDEinhorn LH, Grunberg SM, Rapoport B, Rittenberg C, Feyer P. Antiemetic therapy for multiple-day chemotherapy and additional topics consisting of rescue antiemetics and high-dose chemotherapy with stem cell transplant: review and consensus statement. Support Care Cancer. 2011 Mar;19 Suppl 1:S1-4. doi: 10.1007/s00520-010-0920-z. Epub 2010 May 26.