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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
Pateients enrolled in Tocilizumab group will receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGMDASI questionnaire
MDASI, also as the M. D. Anderson Symptom Inventory, is a brief measure of the severity and impact of cancer related symptoms. Each symptom is rated on an 11-point scale (0 -10) to indicate the presence and severity of the symptom, with 0 meaning "not present" and 10 meaning "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours.
Time frame: day -7~day 100 after stem cells transfusion
Adverse events
recording adverse events according to CTCAE5.0
Time frame: day -7~day 100 after stem cells transfusion
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