drugset / Trial / NCT07413809
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
Phase 3
Recruiting
92 enrolled
The Affiliated People's Hospital of Ningbo University
Dongyang People's Hospital · collabFirst Affiliated Hospital of Wenzhou Medical University · collabJinhua Central Hospital · collabJinhua People's Hospital · collabShaoxing People's Hospital · collabShaoxing Second Hospital · collabTaizhou Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Central Hospital of Lishui City · collabZhejiang Provincial Tongde Hospital · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study employs a prospective, multicenter, randomized, two-arm design aimed at evaluating the efficacy and safety of the FTO regimen in preventing delayed chemotherapy-induced nausea and vomiting (CINV) following high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT). A total of 92 patients with multiple myeloma who were indicated for autologous HSCT were enrolled. The primary endpoint was to compare the complete response (CR) rates of the FTO regimen versus the FTD regimen in the delayed phase (24-240 hours after chemotherapy) for preventing nausea and vomiting induced by high-dose chemotherapy during HSCT.
Timeline
- Start
- 2025-10-31
- Primary completion
- 2027-09
- Completion
- 2027-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 3.75 mg | Oral |
| Comparator | Fosaprepitant | Other / unclassified | 150 mg | Intravenous |
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
| Background | Tropisetron | Small molecule | 5 mg | Intravenous |