Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Rate of Hematologic Complete Response at the completion of 6 cycles
研究概览
简要总结
This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
详细描述
The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
- •Neu≥ 1.0*10^9/L, HGB ≥70g/L, PLT ≥ 50*10^9/L.
- •Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
- •Informed consent explained to, understood by and signed by the patient.
排除标准
- •Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
- •Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- •Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- •Severe or persistent infection that cannot be effectively controlled;
- •Presence of severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
- •Patients with HIV infection or syphilis infection;
- •Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
研究组 & 干预措施
Dara-CyBorD
Daratumumab:
Cyclophosphamide Bortezomib Dexamethasone
干预措施: Dara-CyBorD (Drug)
结局指标
主要结局
Rate of Hematologic Complete Response at the completion of 6 cycles
时间窗: 6 months
Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised.
次要结局
- Renal response at 6 months(6 months)
- Renal Survival in 2 years(2 years)
- Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels(6 months)
- Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels(6 months)
- Cardiac response at 6 months(6 months)
- MRD status at 6 months(6 months)
- Overall Survival in 2 years(2 years)
- TRAEs(2 years)
研究者
Jin Lu, MD
Principal Investigator
Peking University People's Hospital