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Isatuximab-VRd in Transplant-Ineligible Newly Diagnosed Multiple Myeloma Patients (CHAMPION-01)

2026年6月17日 更新者：Peng Liu、Shanghai Zhongshan Hospital

A Single-Arm, Multicenter, Prospective, Observational Clinical Study on the Efficacy and Safety of Isatuximab Combined With Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd) Regimen in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI-NDMM) Patients

Primary Objective of the trial is to evaluate the efficacy and safety of Isa-VRd-based regimen in transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients receiving treatment in real-world clinical practice in China.

And Secondary Objectives is， To assess the MRD negativity rate in Chinese TI-NDMM patients treated with Isa-VRd To assess the safety and tolerability of Isa-VRd in Chinese TI-NDMM patients

Participants will:

Receive Isatuximab 10 mg/kg iv

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Receive Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Receive Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Receive Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen During the induction phase, efficacy assessment is recommended at each treatment cycle. Patients who achieve ≥CR at the end of induction are recommended to undergo the first MRD monitoring assessment.

During the maintenance phase, efficacy assessment is recommended at least every 3 cycles. Patients are recommended to undergo MRD status monitoring (≥CR) every 6 months (i.e., at months 14, 20, and 26) for MRD assessment.

During the follow-up period, MRD status monitoring (≥CR) is recommended every 12 months to observe the depth of response.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is a single-arm, multicenter, prospective observational cohort study with a planned total enrollment of 333 transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) patients aged ≥18 years old in China. All enrolled participants will receive the Isa-VRd induction regimen for 8 cycles (4 weeks per cycle, total 32 weeks). After induction therapy, investigators will determine whether patients continue maintenance treatment based on individual response status, followed by a 2-year long-term follow-up period from the initiation of Isa-VRd treatment, with the maximum observation window of each subject capped at 24 months.

For efficacy evaluation, minimal residual disease (MRD) testing with a cutoff of NGF=10-⁵ will be performed at multiple prespecified time points: at month 8 post-induction, and every 6 months throughout the maintenance and follow-up phase (at months 14, 20 and 26). The primary endpoint of this study is ≥CR rate after induction therapy. Secondary efficacy endpoints include stringent complete response (sCR), very good partial response (VGPR), overall response rate (ORR), duration of response (DOR), time to response (TTR), time to next treatment (TNT), progression-free survival (PFS), overall survival (OS), as well as all safety and tolerability outcomes.

Throughout the entire treatment and follow-up period, all treatment-emergent adverse events (TEAEs), grade ≥3 adverse events, serious adverse events (SAEs), and adverse events of special interest (AESIs, including infusion reactions and second primary malignancies) will be continuously collected and recorded to evaluate the real-world safety profile of the Isa-VRd regimen in Chinese TI-NDMM patients. The overall planned study duration spans approximately 24 months from the first subject's enrollment to the completion of the last patient's 24-month follow-up assessment.

研究の種類

観察的

入学 (推定)

333

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
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 募集
        • Peking Union Medical College Hospital
        • コンタクト：
    • Guangdong
      • Guangzhou、Guangdong、中国
        • 募集
        • Sun Yat-sen University Cancer Center
        • コンタクト：
      • Shenzhen、Guangdong、中国
    • Guangxi
      • Naning、Guangxi、中国、450000
        • 募集
        • The First Affiliated Hospital of Guangxi Medical University
        • コンタクト：
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • 募集
        • Harbin Institute of Hematologic Oncology
        • コンタクト：
    • Henan
    • Hubei
      • Wuhan、Hubei、中国
        • 募集
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
        • コンタクト：
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • 募集
        • Jiangsu Provincial People's Hospital
        • コンタクト：
      • Nantong、Jiangsu、中国
        • 募集
        • Affiliated Hospital of Nantong University
        • コンタクト：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • 募集
        • Fudan University Affiliated Zhongshan Hospital
        • コンタクト：
    • Shanxi
      • Xi’an、Shanxi、中国
        • 募集
        • Xijing Hospital, Air Force Medical University
        • コンタクト：
    • Sichuan
    • Yunnan
      • Kunming、Yunnan、中国
        • 募集
        • The First Affiliated Hospital of Kunming Medical 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

サンプリング方法

非確率サンプル

調査対象母集団

Adult patients (≥18 years old) with newly diagnosed multiple myeloma, ineligible for autologous stem cell transplantation due to age or comorbidities, who are scheduled to receive the Isatuximab + Bortezomib + Lenalidomide + Dexamethasone (Isa-VRd) combination regimen.

説明

Inclusion Criteria:

  • Age ≥18 years
  • Newly diagnosed transplant-ineligible multiple myeloma patients as assessed by investigator, specifically referring to CSCO guidelines

  • Must meet corresponding laboratory test results (refer to restrictions in package inserts of combination drugs):

    • Absolute neutrophil count (ANC) ≥1.0×10⁹/L
    • Platelet count ≥50×10⁹/L
    • Calculated creatinine clearance ≥30 mL/min (using Cockcroft-Gault formula)
    • Total bilirubin ≤3× upper limit of normal (ULN)
  • TI-NDMM patients intended for Isa-VRd regimen treatment as determined by investigator judgment, independent of study objectives Signed informed consent form (by patient or their legal representative)

Exclusion Criteria:

  • Patients currently participating in other interventional clinical studies
  • Patients with known severe hypersensitivity reactions to Isatuximab or any other excipients
  • Severe bacteremia at the time of administration

  • Currently uncontrolled cardiovascular disease, including:

    • Uncontrolled hypertension
    • Uncontrolled arrhythmia
    • Uncontrollable congestive heart failure
    • Unstable angina
  • Patients with peripheral neuropathy ≥Grade 2
  • Active infectious disease, known human immunodeficiency virus (HIV) positivity, active hepatitis B or hepatitis C
  • Patients who are currently pregnant
  • Patients who, at the physician's discretion, are unable to tolerate any drug in the combination regimen

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

コホートと介入

グループ/コホート
介入・治療
Isatuximab Combined with Bortezomib, Lenalidomide, and Dexamethasone（Isa-VRd）regimen

Arm Description:

Isatuximab 10 mg/kg Intravenous injection

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Bortezomib subcutaneous injection 1.3 mg/m²
  • Cycles 1-8: Days 1, 8, and 15 of each cycle Lenalidomide oral 25 mg/day
  • Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Dexamethasone oral 20 mg
  • Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen
薬：Isatuximab

Isatuximab 10 mg/kg Intravenous (IV) infusion

  • Cycle 1: Every weeks on Days 1, 8, 15, and 22
  • Cycles 2-8: Every 2 weeks on Days 1 and 15 Following Cycle 8, the investigator may assess and adjust the treatment regimen Prior to administration of this product, premedication should be given 15-60 minutes before use: acetaminophen 650 mg to 1000 mg orally, H2 receptor antagonist, and diphenhydramine 25 mg to 50 mg intravenously or orally.
他の名前：
  • sarclisa
薬：Bortezomib

Bortezomib subcutaneous injection 1.3 mg/m²

• Cycles 1-8: Days 1, 8, and 15 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

他の名前：
  • Velcade, PS-341
薬：Lenalidomide

Lenalidomide oral 25 mg/day

• Cycles 1-8: Days 1-21 at 25 mg/day (10 mg/day for patients with creatinine clearance [CrCl] ≥30 and <60 mL/min) Following Cycle 8, the investigator may assess and adjust the treatment regimen

他の名前：
  • レブラミド
薬：Dexamethasone

Dexamethasone oral 20 mg

• Cycles 1-8: Days 1, 8, 15, and 22 of each cycle Following Cycle 8, the investigator may assess and adjust the treatment regimen

他の名前：
  • デカドロン

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
≥CR rate after induction treatment
時間枠：After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)
The combined proportion of patients achieving stringent complete response (sCR) and complete response (CR) as assessed according to the 2016 IMWG criteria.
After completion of 8 cycles of induction treatment (approximately 32 weeks or 8 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
MRD negativity rate
時間枠：At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
≥VGPR rate
時間枠：At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Overall response rate
時間枠：At the end of induction phase (Week 32 / approximately 8 months)
At the end of induction phase (Week 32 / approximately 8 months)
Duration of Response
時間枠：From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
From the date of first confirmed response (≥PR) to the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 48 months.
Time to Response
時間枠：Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of first confirmed response (≥PR) as assessed by investigator， assessed up to 24 months
Duration of Treatment
時間枠：Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Time from the start date of Isa-VRd treatment to the date of discontinuation of Isa-VRd regimen for any reason，assessed up to 24 months
Progression free survival
時間枠：Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Time from the start date of Isa-VRd treatment to disease progression (as assessed according to 2016 IMWG criteria) or death from any cause, whichever occurs first，assessed up to 48 months
Overall Survival
時間枠：Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Time from the start date of Isa-VRd treatment to death from any cause，assessed up to 48 months
Incidence Adverse Events
時間枠：From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.
Adverse events (AEs) include treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs), defined as infusion reactions (IRs) and occurrence of second primary malignancies.
From the start date of Isa-VRd treatment through study completion, assessed up to 24 months.

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

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 (推定)

2026年6月1日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2030年9月1日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6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

  • B2026-229

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?

いいえ

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

はい

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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