Phase 3
Completed N=52
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
Source: ClinicalTrials.gov NCT02939287 ↗Enrolled (actual)
52
Serious AEs
16.3%
Results posted
Jan 2024
Primary outcomePrimary: Complete Response (CR) — 4; 11; 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) |
4; 11; 4 | — |
| SECONDARY Acute Complete Response |
— | — |
| SECONDARY Delayed Complete Response |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT02939287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.