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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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

30

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 中国
      • Shanghai、中国
        • 募集
        • Zhongshan Hospital Fudan University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：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.

他の名前：
  • ダラツムマブ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
1-Year Progression-Free Survival (PFS) Rate
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Hematologic Complete Response (Heme-CR) rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Differential gene expression in bone marrow by RNA sequencing between baseline and disease progression in MM-AL patients.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Shanghai Zhongshan Hospital

協力者

Johnson & Johnson

捜査官

  • 主任研究者：Peng Liu、Fudan University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月22日

一次修了 (推定)

2028年7月30日

研究の完了 (推定)

2028年12月30日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月3日

QC基準を満たした最後の更新が送信されました

2026年7月30日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SHZS-MMAL-001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

All IPD that underlie results in a publication

IPD 共有時間枠

starting 6 months after publication

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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