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リンボセルタマブが安全で忍容性が高いかどうか、また最近多発性骨髄腫と診断されたがまだ治療を受けていない参加者にどれだけ効果があるかを知るための機会の窓試験。 (LINKER-MM4)

2026年11月5日 更新者：Regeneron Pharmaceuticals

未治療の症候性多発性骨髄腫患者におけるリンボセルタマブ（抗 BCMA X 抗 CD3 二重特異性抗体）の第 1/2 相試験

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).

The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.

This study consists of 2 phases:

  • In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.
  • In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
  • In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.

The study is looking at several research questions, including:

  • What side effects may happen from taking linvoseltamab?
  • What the right dosing regimen is for linvoseltamab?
  • How many participants treated with linvoseltamab have improvement of their disease and for how long?
  • The effects of linvoseltamab study treatment before and after transplant
  • How much linvoseltamab is in the blood at different times?
  • Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

148

段階

  • フェーズ2
  • フェーズ 1

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。

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095
        • University of California Los Angeles (UCLA)
      • Orange、California、アメリカ、92868
        • UC Irvine Health
    • Colorado
      • Denver、Colorado、アメリカ、80218
        • Colorado Blood Cancer Institute/SCRI
    • Kentucky
      • Louisville、Kentucky、アメリカ、40207
        • Norton Cancer Institute
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • Karmanos Cancer Institute
    • New Jersey
      • New Brunswick、New Jersey、アメリカ、08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Mineola、New York、アメリカ、11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York、New York、アメリカ、10016
        • Perlmutter Cancer Center
      • New York、New York、アメリカ、10032
        • Columbia University _ New York Presbyterian
      • Stony Brook、New York、アメリカ、11794
        • Stony Brook University Hospital
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Levine Cancer Institute
      • Durham、North Carolina、アメリカ、27705
        • Duke University Health System (DUHS)
    • Texas
      • Houston、Texas、アメリカ、77030
        • The University of Texas MD Anderson Cancer Center
  • スペイン
      • Barcelona、スペイン、08036
        • Hospital Clinic de Barcelona
      • Barcelona、スペイン、08908
        • Institut Catala dOncologia (ICO Hospitalet)
      • Madrid、スペイン、28027
        • Clinica Universidad de Navarra - Madrid
      • Madrid、スペイン、28006
        • Universitary Hospital La Princesa
      • Salamanca、スペイン、37007
        • Hospital Universitario de Salamanca
      • Valencia、スペイン、46026
        • Hospital Universitari i Politecnic La Fe
    • Barcelona
      • Badalona、Barcelona、スペイン、08916
        • Hospital Germans Trias i Pujol
    • Madrid
      • Pozuelo de Alarcón、Madrid、スペイン、28223
        • Hospital Universitario Quiron Salud Madrid
    • Navarre
      • Pamplona、Navarre、スペイン、31008
        • Clinica Universidad de Navarra
    • Principality of Asturias
      • Oviedo、Principality of Asturias、スペイン、33011
        • Hospital Universitario Central de Asturias
    • Valencia
      • Alicante、Valencia、スペイン、03010
        • Hospital General Universitario Doctor Balmis Alicante
  • フランス
      • Lille、フランス、59000
        • CHU De Lille
      • Montpellier、フランス、342950
        • Centre Hospitalier Universitaire (CHU) Montpellier
      • Paris、フランス、75010
        • Hopital Saint Louis
      • Paris、フランス、75651
        • University Hospitals Pitie Salpetriere - Charles Foix
    • Vienne
      • Poitiers、Vienne、フランス、86021
        • Centre Hospitalier Universitaire (CHU) de Poitiers
    • Île-de-France Region
      • Antony、Île-de-France Region、フランス、92160
        • Hopital Prive d'Antony
      • Paris、Île-de-France Region、フランス、75015
        • Hopital Necker
      • Villejuif、Île-de-France Region、フランス、94800
        • Gustave Roussy

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  2. Confirmed diagnosis of symptomatic Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
  3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
  4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
  5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
  6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

Key Exclusion Criteria:

  1. Receiving any concurrent investigational agent with known or suspected activity against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/ Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis
  2. Known Central Nervous System (CNS) involvement with MM, known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
  3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
  4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

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：非ランダム化
  • 介入モデル：順次割り当て
  • 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：Phase 1 cohorts

Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.
薬：Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

他の名前：
  • REGN5458
  • Lynozyfic™
実験的：Phase 2 - transplant ineligible cohort

Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
薬：Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

他の名前：
  • REGN5458
  • Lynozyfic™
実験的：Phase 2 - transplant eligible cohort

Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
薬：Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

他の名前：
  • REGN5458
  • Lynozyfic™

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
Incidence of Dose-Limiting Toxicities (DLTs)
時間枠：End of the Observation period; up to day 28

Phase 1
End of the Observation period; up to day 28
Incidence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Severity of TEAEs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of Adverse Events of Special Interest (AESIs)
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
時間枠：Up to 5 years

Phase 2
Up to 5 years
Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
時間枠：Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
時間枠：Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
時間枠：Up to 5 years

Phase 2 Transplant-ineligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
時間枠：Up to 5 years

Phase 2 Transplant ineligible cohort
Up to 5 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Concentrations of Linvoseltamab in serum
時間枠：Post-Last Linvoseltamab Dose, up to 12 weeks

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 12 weeks
Concentrations of total soluble B-Cell Maturation Antigen (BCMA)
時間枠：Post-Last Linvoseltamab Dose, up to 12 weeks

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 12 weeks
Incidence of Anti-Drug Antibodies (ADAs) to Linvoseltamab
時間枠：Post-Last Linvoseltamab Dose, up to 30 days

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 30 days
Magnitude of ADAs to Linvoseltamab
時間枠：Post-Last Linvoseltamab Dose, up to 30 days

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 30 days
Objective Response Rate (ORR) measured using the IMWG criteria
時間枠：Up to 5 years

Phase 1
Up to 5 years
Duration Of Response (DOR) measured using the IMWG criteria
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Progression-Free Survival (PFS) measured using the IMWG criteria
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Proportion of participants achieving MRD-negative status (at 10^-5) in participants with NDMM measured using the IMWG criteria
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of TEAEs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Severity of TEAEs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of AESIs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
時間枠：Up to 5 years

Phase 2
Up to 5 years
MRD-negative status of participants deemed transplant-eligible and transplant-ineligible by the treating physician
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
PFS of participants deemed transplant-eligible and transplant-ineligible by the treating physician
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Time To Response (TTR) as measured using the IMWG criteria
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
ORR by risk levels
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
MRD-negative status by risk levels
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
DOR by risk levels
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
TTR by risk levels
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
PFS by risk levels
時間枠：Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of MRD-negative status
時間枠：Up to 5 years

Phase 2
Up to 5 years
Cluster of Differentiation 34+ (CD34+) stem cell yield
時間枠：At cycle 4 of induction (each cycle is 28 days long)

Phase 2 Transplant-eligible cohort
At cycle 4 of induction (each cycle is 28 days long)
Time to neutrophil engraftment
時間枠：Up to 100 days post-transplant

Phase 2 Transplant-eligible cohort
Up to 100 days post-transplant
Time to platelet engraftment
時間枠：Up to 100 days post-transplant

Phase 2 Transplant-eligible cohort
Up to 100 days post-transplant
PFS after ASCT followed by 3 cycles of linvoseltamab
時間枠：Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 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

Regeneron Pharmaceuticals

捜査官

  • スタディディレクター：Clinical Trial Management、Regeneron Pharmaceuticals

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)

2023年12月19日

一次修了 (推定)

2035年11月2日

研究の完了 (推定)

2035年11月2日

試験登録日

最初に提出

2023年4月12日

QC基準を満たした最初の提出物

2023年4月12日

最初の投稿 (実際)

2023年4月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月5日

最終確認日

2026年11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

  • R5458-ONC-2158
  • 2022-500800-24-00 (Ctis)

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 Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD 共有時間枠

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共有アクセス基準

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • 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

はい

米国FDA規制機器製品の研究

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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