Mitoxantrone Hydrochloride Liposome Injection, Bortezomib and Dexamethasone in the Treatment of R/R MM
2022年1月16日 更新者:CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
研究概览
地位
招聘中
条件
详细说明
This is a multicenter, open-label, phase I study aimed to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
In the study, 60 patients will be recruited into three dose groups.
All patients will receive the treatment for the planned 8 cycles(28 days per cycle)until disease progression or unacceptable drug-related adverse events
研究类型
介入性
注册 (预期的)
60
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Na An
- 电话号码:+86-010-63930582
- 邮箱:anna@mail.ecspc.com
学习地点
-
-
Beijing
-
Beijing、Beijing、中国
- 招聘中
- Beijing Chaoyang Hospital, Capital Medical University
-
接触:
- Wenming Chen, Doctor
- 电话号码:13910107759
- 邮箱:13910107759@163.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients fully understand and voluntarily participate in this study and sign informed consent;
- Aged 18-75 years, without gender limitation;
- Patients with relapsed or refractory multiple myeloma(confirmed by histologically or cytologically) who had received at least one prior line regular treatment;
- Patients have at least one of the following conditions:(1)Serum M protein≥10g/L;(2)Urine M protein≥200 mg/24h; (3)Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥100mg /L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
Laboratory tests meet the following conditions:
- Absolute neutrophil count (ANC) ≥1.5x10^9/L (No G-CSF treatment within 1 week prior to the laboratory test);
- Platelet count ≥ 75x10^9/L (No platelet transfusion within 1 week prior to the laboratory test);
- Total bilirubin ≤1.5upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN;
- Creatinine clearance(Ccr) ≥30mL/min.
- Females of childbearing potential must have a negative serum beta human chorionic gonadotrophin (β-hCG) pregnancy test result prior to enrollment and must agree to use an effective contraception method for the duration of the study treatment and 7 months after the last dose of study therapy.
Males patients and their partners must agree to use an effective contraceptive method for the duration of the study treatment and 4 months after the last dose of study therapy.
-
Exclusion Criteria:
- Patients with amyloidosis or central nervous system invasion or on dialysis treatment.
- Life expectancy < 3 months.
- History of allergy to mitoxantrone hydrochloride or liposomes;or previous treatment with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) ≥350 mg/m^2.
- History of allergy (except local injection reaction) or intolerance to bortezomib;or one of the following conditions occurred with prior bortezomib regimens: no treatment response (not reach MR),disease progression within 6 months after the end of last dose.
- History of contraindications or intolerance to dexamethasone.
- Any anti-myeloma drug treatment or radiotherapy within 4 weeks prior to the first dose; or enrolled in any other clinical trials of anti-myeloma drug within 3 months prior to the first dose.
- History of autologous hematopoietic stem cell transplantation within 6 months prior to screening.
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Adverse events from the previous treatment have not resolved to ≤ Grade 1 (except for alopecia, hyperpigmentation).
- Patients with persistent Grade≥2 peripheral neuropathy or Grade 1 peripheral neuropathy with pain.
- Patients with impaired cardiac function or significant cardiac disease.
- HBsAg/HBcAb positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center,or human immunodeficiency virus (HIV) antibody positive.
- Patients with obvious digestive system dysfunction, which may affect intake, transport and absorption of the study drug.
- Active bacterial, fungal or viral infections that require systemic treatment within 1 week prior to the first dose
- Patients underwent major surgery within 6 weeks prior to the first dose, or had a surgical schedule during the study period;
- History of additional malignant tumor within 5 years, except for locally curable cancer that has been cured.
- Other medical conditions that, in the judgment of the investigator, may affect the patient's participation in this study.
- Pregnant or breastfeeding women;
Not suitable for this study as decided by the investigator due to other reasons.
-
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:12 mg/m ^ 2 dose group (ArmA)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 12 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
其他名称:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
其他名称:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
其他名称:
|
实验性的:16 mg/m ^ 2 dose group (ArmB)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 16 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
其他名称:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
其他名称:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
其他名称:
|
实验性的:20 mg/m ^ 2 dose group (ArmC)
Patients with relapsed or refractory multiple myeloma will receive mitoxantrone hydrochloride liposome in combination with bortezomib and dexamethasone for 8 cycles (planned) (28 days per cycle).
The dose of mitoxantrone hydrochloride liposome is 20 mg/m^2
|
Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
其他名称:
Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
其他名称:
Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Treatment-emergent adverse events (TEAEs)
大体时间:From the initiation of the first dose to 28 days after the last dose
|
To indentify the incidence of TEAEs
|
From the initiation of the first dose to 28 days after the last dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective response rate (ORR)
大体时间:Throughout the study treatment(Up to 32 weeks)
|
ORR is defined as the proportion of patients who have a best overall response of partial response (PR),very good partial response(VGPR), complete response (CR) or stringent complete response (sCR) as per International Myeloma Working Group (IMWG)
|
Throughout the study treatment(Up to 32 weeks)
|
Clinical Benefit Rate(CBR)
大体时间:Throughout the study treatment(Up to 32 weeks)
|
CBR is defined as the proportion of patients who have a best overall response of minimal response(MR),PR,VGPR,CR or sCR as per IMWG
|
Throughout the study treatment(Up to 32 weeks)
|
Disease control rate(DCR)
大体时间:Throughout the study treatment(Up to 32 weeks)
|
DCR is defined as the proportion of patients who have a best overall response of stable disease (SD),MR,PR,VGPR,CR or sCR as per IMWG
|
Throughout the study treatment(Up to 32 weeks)
|
Duration of response (DoR)
大体时间:Throughout the study completion.(An average of 12 months)
|
DoR is defined as the time from the first assessment of PR,VGPR,CR orsCR until the date of first occurrence of progressive disease (PD) as per IMWG
|
Throughout the study completion.(An average of 12 months)
|
Progression-free survival (PFS)
大体时间:Throughout the study completion.(An average of 12 months)
|
PFS is defined as the time from the date of first dose until the date of first documented PD as per IMWG or death from any cause, whichever occurs first
|
Throughout the study completion.(An average of 12 months)
|
Overall survival (OS)
大体时间:Throughout the study completion.(An average of 36 months)
|
OS is defined as the time from the date of first dose until the date of death from any cause
|
Throughout the study completion.(An average of 36 months)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Wenming Chen、Beijing Chaoyang Hospital affiliated to Capital Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月20日
初级完成 (预期的)
2023年4月20日
研究完成 (预期的)
2024年6月20日
研究注册日期
首次提交
2021年9月13日
首先提交符合 QC 标准的
2021年9月13日
首次发布 (实际的)
2021年9月22日
研究记录更新
最后更新发布 (实际的)
2022年2月1日
上次提交的符合 QC 标准的更新
2022年1月16日
最后验证
2022年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HE071-CSP-023
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Mitoxantrone Hydrochloride Liposome injection的临床试验
-
Tianjin Medical University Cancer Institute and...CSPC Ouyi Pharmaceutical Co., Ltd.尚未招聘