Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen

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.

Conditions

• Multiple Myeloma

Interventions

DRUG

Fosaprepitant

150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT

DRUG

Fosaprepitant

150mg, intravenously 30 minutes before chemotherapy on day -3

DRUG

Tropisetron

5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2

DRUG

Olanzapine

5mg, orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurs first

DRUG

Dexamethasone

6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0

Sponsors & Collaborators

• Zhejiang University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Jinhua Central Hospital

  collaborator OTHER

• Shaoxing People's Hospital

  collaborator OTHER

• Shaoxing Second Hospital

  collaborator OTHER

• Jinhua People's Hospital

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• The Affiliated People's Hospital of Ningbo University

  lead OTHER_GOV

Principal Investigators

• Peipei Ye · The Affiliated People's Hospital of Ningbo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• China

Study Locations