이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

린보셀타맙이 안전하고 내약성이 좋은지, 그리고 아직 치료를 받지 않은 최근 진단된 다발성 골수종 환자에게 얼마나 잘 작용하는지 알아보기 위한 기회 시험의 창. (LINKER-MM4)

2026년 11월 5일 업데이트: Regeneron Pharmaceuticals

치료 경험이 없는 증상성 다발성 골수종 환자를 대상으로 한 린보셀타맙(항BCMA X 항CD3 이중특이성 항체)의 1/2상 연구

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).

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

148

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

다른 이름들:
  • REGN5458
  • Lynozyfic ™
실험적: Phase 2 - transplant ineligible cohort

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

Linvoseltamab will be administered by intravenous (IV) infusion

다른 이름들:
  • REGN5458
  • Lynozyfic ™
실험적: 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
의약품: Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

다른 이름들:
  • REGN5458
  • Lynozyfic ™

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Dose-Limiting Toxicities (DLTs)
기간: 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)
기간: Post-Last Linvoseltamab Dose, up to 90 days

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

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 5 years

Phase 2 Transplant ineligible cohort
Up to 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Concentrations of Linvoseltamab in serum
기간: 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)
기간: 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
기간: 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
기간: 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
기간: Up to 5 years

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

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

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

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

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

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

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

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

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

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

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

Phase 2
Up to 5 years
Cluster of Differentiation 34+ (CD34+) stem cell yield
기간: 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
기간: Up to 100 days post-transplant

Phase 2 Transplant-eligible cohort
Up to 100 days post-transplant
Time to platelet engraftment
기간: 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
기간: Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Regeneron Pharmaceuticals

수사관

  • 연구 책임자: Clinical Trial Management, Regeneron Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 12월 19일

기본 완료 (추정된)

2035년 11월 2일

연구 완료 (추정된)

2035년 11월 2일

연구 등록 날짜

최초 제출

2023년 4월 12일

QC 기준을 충족하는 최초 제출

2023년 4월 12일

처음 게시됨 (실제)

2023년 4월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다