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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).

2026年7月30日 更新者：Peng Liu、Shanghai Zhongshan Hospital

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)

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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段2

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

研究联系人备份

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age ≥18 years, any sex/gender
  2. Diagnosis of multiple myeloma according to IMWG criteria

  3. Histopathologic diagnosis of AL amyloidosis confirmed by:

    • Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:

      1. Immunohistochemistry and/or immunofluorescence
      2. Mass spectrometry
      3. Electron microscopy/immunoelectron microscopy
  4. Measurable disease at screening
  5. Newly diagnosed, no prior anti-plasma cell therapy

  6. 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
  7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study
  8. Voluntarily signed informed consent form (ICF)

Exclusion Criteria:

  1. Prior anti-myeloma therapy or stem cell transplantation
  2. 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
  3. Active infection or autoimmune disease
  4. Uncontrolled diabetes, hypertension, or other comorbidities
  5. Pregnant or lactating female
  6. Currently participating in another interventional study
  7. Any other condition that the investigator considers unsuitable for study participation

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：不适用
  • 介入模型：单组作业
  • 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：Treatment Group

Teclistamab (subcutaneous injection) with step-up dosing: 0.06 mg/kg, 0.3 mg/kg, and 1.5 mg/kg on Days 1, 3, and 5 of Cycle 1, 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.

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.

Treatment continues until disease progression, unacceptable toxicity, or a maximum of 24 cycles (approximately 2 years).
药品：Teclistamab

Teclistamab: A humanized IgG4-PAA bispecific antibody targeting BCMA and CD3. It bridges malignant plasma cells and CD3+ T cells, leading to T cell activation and perforin/granzyme-mediated lysis of BCMA+ tumor cells.

Daratumumab: A humanized IgG1κ monoclonal antibody targeting CD38, which induces tumor cell lysis through complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and antibody-dependent cellular phagocytosis. It also enhances T cell-mediated anti-myeloma immunity by increasing cytotoxic T helper cells and depleting CD38+ immunoregulatory cells, thereby potentiating teclistamab's activity.

其他名称：
  • 达雷木单抗

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
1-Year Progression-Free Survival (PFS) Rate
大体时间：From the start of treatment to 1 year, or until disease progression or death, whichever occurs first
The percentage of participants who are alive and free from disease progression at 1 year after initiation of Tec-Dara treatment. Progression is defined according to IMWG criteria, including increase in serum M protein, urine M protein, or serum free light chain; development of new bone lesions or soft tissue plasmacytomas; or hypercalcemia.
From the start of treatment to 1 year, or until disease progression or death, whichever occurs first

次要结果测量

结果测量
措施说明
大体时间
Hematologic Complete Response (Heme-CR) rate
大体时间：Up to 24 cycles (approximately 2 years)
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response. Heme-CR rate is the percentage of participants who achieve CR prior to subsequent anti-myeloma therapy, during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Very Good Partial Response or Better (≥VGPR) Rate
大体时间：Up to 24 cycles (approximately 2 years)
Heme-VGPR is defined as a reduction in the dFLC to <40 mg/L. ≥VGPR rate is the percentage of participants achieving VGPR and CR prior to subsequent anti-myeloma therapy during or after the study treatment.
Up to 24 cycles (approximately 2 years)
Minimal Residual Disease (MRD) Negativity Rate
大体时间：6 months and 12 months, and up to 24 cycles (approximately 2 years)
Proportion of participants achieving MRD negativity at a sensitivity threshold of 10^-5, assessed by next-generation flow cytometry (NGF) or next-generation sequencing (NGS). The MRD-negativity rate by 6 and 12 months will be reported descriptively.
6 months and 12 months, and up to 24 cycles (approximately 2 years)
Organ Response Rate
大体时间：Up to 24 cycles (approximately 2 years)
Proportion of participants achieving organ response according to consensus criteria for AL amyloidosis, based on changes in NT-proBNP, cardiac troponin T/I, and estimated glomerular filtration rate (eGFR).
Up to 24 cycles (approximately 2 years)
Time to First Response
大体时间：Up to 24 cycles (approximately 2 years)
Time from the start of treatment to the first documented PR or better response according to IMWG criteria.
Up to 24 cycles (approximately 2 years)
Duration of Response
大体时间：Up to 3 years from study start
Time from the start of treatment to death from any cause.
Up to 3 years from study start
Median Progression-Free Survival
大体时间：Up to 3 years from study start
Time from the start of treatment to disease progression or death from any cause, whichever occurs first.
Up to 3 years from study start
Time to Next Treatment
大体时间：Up to 3 years from study start
Time from the start of treatment to the initiation of first subsequent anti-myeloma therapy.
Up to 3 years from study start
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
大体时间：Through study completion, up to 12 months after the end of study treatment.
Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0. A participant with multiple adverse events of the same preferred term will be counted once. Adverse events will be summarized by frequency, severity (graded by CTCAE v5.0), and causality, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, hematologic toxicities, and infusion-related reactions.
Through study completion, up to 12 months after the end of study treatment.

其他结果措施

结果测量
措施说明
大体时间
Differential gene expression in bone marrow by RNA sequencing between baseline and disease progression in MM-AL patients.
大体时间：Baseline and up to 3 years.
Bone marrow transcriptome profiles will be analyzed by RNA sequencing at baseline and at disease progression to identify differentially expressed genes, altered signaling pathways, and molecular signatures predictive of disease progression in MM-AL patients. Data will be summarized as fold-change in gene expression, pathway enrichment scores, and predictive model performance metrics (e.g., AUC, sensitivity, specificity).
Baseline and up to 3 years.

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。

赞助

Shanghai Zhongshan Hospital

合作者

Johnson & Johnson

调查人员

  • 首席研究员：Peng Liu、Fudan 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)

2026年5月22日

初级完成 (估计的)

2028年7月30日

研究完成 (估计的)

2028年12月30日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月30日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SHZS-MMAL-001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All IPD that underlie results in a publication

IPD 共享时间框架

starting 6 months after publication

IPD 共享访问标准

IPD could be requested by contacting the corresponding author via email after publication.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

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

在美国制造并从美国出口的产品

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.

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