Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma:A Single-arm, Single-center, Prospective Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
详细描述
This study is expected to be carried out from November 2023 to November 2026. About 30 patients with high-risk/extramedullary multiple myeloma will receive mitoxantrone Hydrochloride Liposome combination regimen treatment. After evaluating of efficacy and safety of treatment, the principal investigator will write and publish the paper.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test) or extramedullary multiple myeloma;
- •Age: 18-70 years old (including 18 and 70 years old), regardless of gender;
- •Eastern Cooperative Oncology Group physical performance score (ECOG): 0-2 points;
- •Expected survival ≥3 months;
- •Have "measurable lesions": extramedullary lesions ≧1.0cm or more; serum M protein ≥10g/L and/or 24-hour urine M protein ≥200mg;
- •Blood routine: neutrophil count ≥1.0×109/L; for patients with plasma cells in bone marrow >50%, 0.5×109/L≤neutrophil count <1.0×109/L is allowed. For patients with platelets ≥100×109/L; plasma cells in bone marrow >50%, 50×109/L≤platelets <100×109/L; hemoglobin >8g/dL;
- •Liver function: AST and ALT ≤ 2.5 times the upper limit of normal value (for the same age group), or ≤ 5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin ≤ 1.5 times the upper limit of normal value; creatinine ≤ 2.5 mg/dL ;
- •Patients receiving localized radiation therapy, with or without concomitant steroids, for pain control or spinal cord/nerve root compression treatment are eligible. More than 4 weeks since the last radiotherapy treatment;
- •Sign the informed consent form.
排除标准
- •Impaired heart function or suffering from significant heart disease, including but not limited to:
- •Myocardial infarction or viral myocarditis occurred within 6 months before screening;
- •There are heart diseases that require treatment at the time of screening, such as unstable angina, chronic congestive heart failure (NYHA ≥ grade 2), arrhythmia, valvular disease, etc. or persistent cardiomyopathy;
- •QTc interval >480ms or suffering from long QTc syndrome during screening;
- •The cardiac ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center during screening.
- •Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL);
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- •Suffer from uncontrollable bacterial infection, fungal infection or viral infection that requires systemic treatment within 1 week before the administration of the study drug;
- •Women who are pregnant or breastfeeding;
- •Peripheral neuropathy or pain of grade 2 (CTCAE5.0) or above before treatment;
- •Received systemic chemotherapy within 28 days before the first dose;
- •Relapsed patients are resistant to pomalidomide in previous treatment or cannot accept pomalidomide treatment
研究组 & 干预措施
Lipo-MIT combination regimen group
Initial diagnosis induction treatment regimen Lipo-MIT +VD (VMD):
Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Bortezomib: 1.3mg/m2 d1, 4, 8, 11, subcutaneous injection; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of VMD regimen induction therapy are performed.
Reinduction therapy regimen after relapse Lipo-MIT + PD (PMD):
Mitoxantrone Hydrochloride Liposome: 10 mg, d1, d15, intravenous infusion; Pomalidomide: 4 mg/d d1-d21, orally; Dexamethasone: 20 mg/d, orally on days 1, 2, 4, 5, 8, 9, 11, and 12. Every 4 weeks constitutes a cycle, and 4 cycles of PMD regimen induction therapy are performed.
干预措施: Lipo-MIT combination regimen (Drug)
结局指标
主要结局
ORR
时间窗: 6 months
objective remission rate
次要结局
- TTNT(2 year)
- 2-years extramedullary relapse rate(2 years)
- 2-years PFS(2 years)
- MRD negative conversion rate(6 months)
- 2-years OS(2 years)
- DoR(2 years)
研究者
Hongming Huang
professor
Affiliated Hospital of Nantong University