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Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

Official title:
Study of Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following High-dose Melphalan Conditioning in Patients With Multiple Myeloma

Clinical Trial Summary

Background: Autologous hematopoietic stem cell transplantation(ASCT) is an important part treatment for patients with multiple myeloma. Retrospective analysis from our center showed that incidence of oral mucositis and gastrointestinal symptoms was higher during ASCT for melphalan as conditioning regimen in patients with multiple myeloma. Objective: Safety and optimization of ASCT-related symptom burden of tocilizumab for melphalan as a conditioning regimen in ASCT for multiple myeloma is explored. Methods: The patient who is enrolled will be randomly divided into two groups in a proportion of 1:1 to respectively receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells or not. There will be enroll 48 patients according to inclusion and exclusion criteria totally. Adverse events and MDASI score during ASCT between two groups will be recorded and analyzed. Primary endpoint: MDASI, Security; Secondary endpoints: time to neutrophil engraftment; time of platelet implantation; efficacy (ORR) after autologous hematopoietic stem cell transplantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05855122
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact chengcheng Fu, PhD
Phone 051267781856
Email fuzhengzheng@suda.edu.cn
Status Recruiting
Phase Phase 4
Start date April 17, 2023
Completion date December 31, 2024
View Details
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