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NCT06588413 · ClinicalTrials.gov registry record · Phase 3
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
A Phase 3 study of Multiple Myeloma and Autologous Stem Cell Transplantation, sponsored by Augusta University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
- 1
- Study location
NCT06588413: Recruiting Phase 3 study of Multiple Myeloma and Autologous Stem Cell Transplantation, sponsored by Augusta University.
NCT06588413 is a Phase 3 study of Multiple Myeloma and Autologous Stem Cell Transplantation that is actively recruiting participants, run by Augusta University. The registered enrollment target is 172 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06588413, a Phase 3 study of Multiple Myeloma and Autologous Stem Cell Transplantation, is actively recruiting participants, sponsored by Augusta University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.
Primary Outcome
The primary objective is to compare the percentage of patients achieving chemotherapy-induced nausea and vomiting (CINV) complete response (CR), where CR is defined as no emesis and no more than mild nausea (\</=1 score on a 4-point categorical scale \[0 = none, 1 = mild, 2 = moderate, and 3 = severe\]) during the overall assessment period (defined as the day of chemotherapy through 5 days after chemotherapy).
Conditions Studied
Interventions
- DRUG Olanzapine
Study Locations (1)
Georgia
- Wellstar MCG - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What NCT06588413 shows while recruiting
NCT06588413 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Olanzapine is the first listed.
NCT06588413 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06588413 about?
NCT06588413 is a clinical study titled "Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan". Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications us...
What is the current status of trial NCT06588413?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2024-09-17. Estimated completion is 2027-10.
What conditions does trial NCT06588413 study?
This clinical trial studies the following conditions: Multiple Myeloma, Autologous Stem Cell Transplantation.
What interventions are being tested in trial NCT06588413?
The interventions under investigation include: Olanzapine (DRUG).
Who is sponsoring clinical trial NCT06588413?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06588413 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06588413's enrollment target sits among peer trials
172 124th of 438 higher than 315 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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