A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination. The main questions it aims to answer are:
Does Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara?
Participants will:
Receive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg/kg), followed by 1.5 mg/kg weekly in Cycle 1, 3.0 mg/kg every 2 weeks in Cycles 2-3, and 3.0 mg/kg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis
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
- •Age ≥18 years, any sex/gender
- •Diagnosis of multiple myeloma according to IMWG criteria
- •Histopathologic diagnosis of AL amyloidosis confirmed by:
- •Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:
- •Immunohistochemistry and/or immunofluorescence
- •Mass spectrometry
- •Electron microscopy/immunoelectron microscopy
- •Measurable disease at screening
- •Newly diagnosed, no prior anti-plasma cell therapy
- •Adequate laboratory values:
- •Hemoglobin ≥7.5 g/dL
- •Absolute neutrophil count ≥1.0×10⁹/L
- •Platelet count ≥70×10⁹/L (platelet transfusion acceptable; >50×10⁹/L if ≥50% bone marrow nucleated cells are plasma cells)
- •ALT ≤2.5× upper limit of normal (ULN)
- •AST ≤2.5× ULN
- •Total bilirubin ≤2.0× ULN
- •Creatinine clearance ≥30 mL/min
- •Corrected serum calcium ≤14 mg/dL
- •Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
- •Voluntarily signed informed consent form (ICF)
排除标准
- •Prior anti-myeloma therapy or stem cell transplantation
- •Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment
- •Active infection or autoimmune disease
- •Uncontrolled diabetes, hypertension, or other comorbidities
- •Pregnant or lactating female
- •Currently participating in another interventional study
- •Any other condition that the investigator considers unsuitable for study participation
研究者
Peng Liu
Professor, Chief Physician
Shanghai Zhongshan Hospital