Study of Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following High-dose Melphalan Conditioning in Patients With Multiple Myeloma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- MDASI questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma eligible for autologous hematopoietic stem cell transplantation;
- •Secretory MM should have measurable markers, including:
- •specific M protein value (≥5g/L)；
- •and/or involved flc ≥100mg/L；
- •and/or measurable extramedullary foci (diameter>1cm on CT);
- •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.
排除标准
- •With ≥2 degree of peripheral neuropath or with pain;
- •Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed;
- •With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction;
- •Patients in pregnancy or lactation;
- •Allergic constitution or being allergic to any drug within the regimen of the trial;
- •With uncontrolled mental diseases;
- •With active infection;
- •With active hepatitis;
- •HIV positive;
- •History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma;
- •With other conditions that the investigators think unfit for the trial.
研究组 & 干预措施
Tocilizumab
干预措施: Tocilizumab (Drug)
结局指标
主要结局
MDASI questionnaire
时间窗: day -7~day 100 after stem cells transfusion
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.
Adverse events
时间窗: day -7~day 100 after stem cells transfusion
recording adverse events according to CTCAE5.0
次要结局
未报告次要终点
研究者
Fu chengcheng PhD
Principal Investigator
The First Affiliated Hospital of Soochow University