Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental |
| |
| no-Tocilizumab | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Pateients enrolled in Tocilizumab group will receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MDASI 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. | day -7~day 100 after stem cells transfusion |
| Adverse events | recording adverse events according to CTCAE5.0 | day -7~day 100 after stem cells transfusion |
Not provided
Not provided
Inclusion Criteria:
Patients with multiple myeloma eligible for autologous hematopoietic stem cell transplantation;
Secretory MM should have measurable markers, including:
Age ≥ 18 years and ≤ 70 years, male or female;
PR and above are obtained after induction therapy according to the IMWG response criteria;
Mononuclear cells ≥2×10^8/kg body weight, CD34+ cells≥2×10^6/kg body weight;
ECOG 0-2, with life expectance ≥3 months;
ALT/AST level ≤2.5 times of the maximum of normal range; total bilirubin≤2 times of normal maximum;
Neutrophil count≥ 1.5×10^9/L, platelet count ≥50×10^9/L;
Normal Left ventricular ejection fraction , NYHA stage 1, lung function GOLD stage 1;
Willing to accept the possibility of potential adverse events and efficacy observation by the investigators;
Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chengcheng Fu, PhD | Contact | 051267781856 | fuzhengzheng@suda.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided