A Prospective, Open-label, Single-arm Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Daratumumab and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
A prospective, open-label, single-arm clinical study of mitoxantrone hydrochloride liposome injection combined with daratumumab and dexamethasone in the treatment of relapsed/refractory multiple myeloma
详细描述
This study is a prospective, open-label, single-arm study. It is expected to include 20 patients with relapsed/refractory multiple myeloma who will receive combined treatment. The recommended dose of mitoxantrone hydrochloride liposome injection is 20mg/m2 (the dose can be adjusted according to the patient's tolerance, but the minimum dose is not less than 12mg/m2). Each cycle is 4 weeks long and the maximum number of cycles is 6.
Dexamethasone 20 mg/d, on the same day of daratumumab injection; Mitoxantrone hydrochloride liposome injection: 20 mg/m2, d1; Daratumumab: 16 mg/Kg, once a week for the first 8 weeks; then changed to once every two weeks; The study includes a screening period (within 28 days), a treatment period (up to 6 cycles), and a follow-up period (safety follow-up, survival follow-up, planned for 2 years).
The subjects signed an informed consent form and underwent baseline examination during the screening period. Eligible patients were enrolled in the treatment period. All subjects underwent relevant examinations as stipulated in the protocol during the treatment process to observe efficacy and safety. After the treatment period ends, they will enter the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age :18-75 years, male or female;
- •Meet the definition of relapsed/refractory multiple myeloma;
- •At least one of the following can be evaluated:
- •Blood M protein level ≥10g/L;
- •24-hour urine M protein level ≥200mg;
- •The difference between involved and uninvolved serum free light chain (dFLC) ≥100mg/L;
- •Extramedullary lesions with a diameterday≥2cm;
- •ECOG score 0-2 points;
- •Laboratory tests meet the following criteria:
- •Absolute neutrophil count (ANC) ≥1.0x109/L;
- •Platelets (PLT) ≥50x109/L;
- •Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN;
- •Creatinine clearance rate (Ccr) ≥30ml/min.
排除标准
- •1.Expected survival time <3 months. 2.History of allergy to mitoxantrone or liposomal drugs; previous treatment with mitoxantrone or other anthracycline therapy, total cumulative dose of mitoxantrone >360 mg/m2 (other anthracycline drugs are equivalent to 1mg mitoxantrone, 2mg doxorubicin or 0.5mg epirubicin).
- •3.Impaired cardiac function or significant heart disease, including but not limited to: a) Myocardial infarction or viral myocarditis within 6 months before screening. b) Existing heart disease requiring treatment at the time of screening, such as unstable angina pectoris, chronic congestive heart failure (NYHA≥2), arrhythmia, valve disease, etc., or persistent myocardial disease. c) QTc interval>480ms at screening or long QTc syndrome. d) Ejection fraction less than 50% at screening or lower than the lower limit of the study center's examination value range.
- •4.HBsAg or HBcAb positive and HBV-DNA titer higher than the lower limit of the study center's detection value, or HCV antibody positive and HCV-RNA titer higher than the lower limit of the study center's detection value, or HIV antibody positive.
- •5.Bacterial infection, fungal infection or viral infection requiring systemic treatment within 1 week before administration of the study drug.
- •6.Pregnant or lactating women. 7.Other situations judged by investigator as inappropriate for participation in this study.
研究组 & 干预措施
MDD group
Dexamethasone 20 mg/d, on the same day of daratumumab injection; Mitoxantrone hydrochloride liposome injection: 20 mg/m2, d1; Daratumumab: 16 mg/Kg, once a week for the first 8 weeks; then changed to once every two weeks; Each cycle is 4 weeks long and the maximum number of cycles is 6.
干预措施: Mitoxantrone hydrochloride liposome/Dexamethasone/daratumumab (Drug)
结局指标
主要结局
ORR
时间窗: 6 months
Objective response rate (ORR): Objective response includes partial response (PR), very good partial response (VGPR), complete response (CR), and strictly defined complete response (sCR).
次要结局
- 1-year PFS rate(1 year)
- 1-year extramedullary relapse rate.(1 year)
- Adverse Eventsl(6 months)
- DoR(1 year)
- 1-year PFS OS(1 year)