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临床试验/NCT07222761
NCT07222761招募中3 期

An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

Regeneron Pharmaceuticals24 个研究点 分布在 5 个国家目标入组 915 人开始时间: 2026年1月2日最近更新:
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干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
915
试验地点
24
主要终点
Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
  • •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
  • •Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

排除标准

  • •Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
  • •Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • •Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  • •History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
  • •NOTE: Other protocol defined inclusion/exclusion criteria apply

研究组 & 干预措施

Part 2: Arm C

Experimental

干预措施: Bortezomib (Drug)

Part 2: Arm C

Experimental

干预措施: Daratumumab (Drug)

Part 2: Arm A

Experimental

干预措施: Linvoseltamab (Drug)

Part 2: Arm B

Experimental

干预措施: Carfilzomib (Drug)

Part 2: Arm C

Experimental

干预措施: Dexamethasone (Drug)

Part 1: Arm A

Experimental

干预措施: Linvoseltamab (Drug)

Part 2: Arm B

Experimental

干预措施: Linvoseltamab (Drug)

Part 1: Arm B

Experimental

干预措施: Carfilzomib (Drug)

Part 2: Arm C

Experimental

干预措施: Carfilzomib (Drug)

Part 2: Arm C

Experimental

干预措施: Pomalidomide (Drug)

Part 1: Arm B

Experimental

干预措施: Linvoseltamab (Drug)

结局指标

主要结局

Occurrence of Treatment Emergent Adverse Events (TEAEs)

时间窗: Up to 5 years

Part 1

Severity of SAEs

时间窗: Up to 5 years

Part 1

Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

时间窗: Up to 5 years

Part 2

Severity of TEAEs

时间窗: Up to 5 years

Part 1

Severity of AESIs

时间窗: Up to 5 years

Part 1

Occurrence of Adverse Events of Special Interest (AESI)

时间窗: Up to 5 years

Part 1

Occurrence of Serious Adverse Events (SAEs)

时间窗: Up to 5 years

Part 1

Minimal Residual Disease (MRD)-negative Complete Response (CR)

时间窗: At 12 months

Part 2

次要结局

  • Time To Next Treatment (TTNT)(Up to 5 years)
  • Second PFS(Up to 5 years)
  • MRD-negative CR criteria at any time(Up to 5 years)
  • Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC(Up to 5 years)
  • Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)(Up to 28 days)
  • Timing of grade ≥2 CRS(Up to 28 days)
  • Overall Survival (OS)(Up to 7 years)
  • Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC(Up to 5 years)
  • Achievement of CR or better per IMWG response criteria as determined by BIRC(Up to 5 years)
  • Duration Of Response (DOR) as per IMWG response criteria(Up to 5 years)
  • Time To Progression (TTP) as per IMWG response criteria(Up to 5 years)
  • Time to PR IMWG response category(Up to 5 years)
  • Time to VGPR IMWG response category(Up to 5 years)
  • Time to CR IMWG response category(Up to 5 years)
  • Time to stringent Complete Response (sCR) IMWG response category(Up to 5 years)
  • Sustained MRD-negative CR(Up to 5 years)
  • Duration of MRD-negative CR(Up to 5 years)
  • Occurrence of TEAEs(Up to 5 years)
  • Severity of TEAEs(Up to 5 years)
  • Occurrence of AESIs(Up to 5 years)
  • Severity of AESIs(Up to 5 years)
  • Occurrence of SAEs(Up to 5 years)
  • Severity of SAEs(Up to 5 years)
  • Concentrations of linvoseltamab in serum over time(Up to 5 years)
  • Incidence of Antidrug Antibodies (ADAs) to linvoseltamab(Up to 5 years)
  • Magnitude of ADAs to linvoseltamab(Up to 5 years)
  • Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time(Up to 5 years)
  • Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(Up to 5 years)
  • Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30(Up to 5 years)
  • Change from baseline in Role Functioning (RF), per EORTC QLQ-C30(Up to 5 years)
  • Change from baseline in pain, per EORTC QLQ-C30(Up to 5 years)
  • Change from baseline in fatigue, per EORTC QLQ-C30(Up to 5 years)
  • Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])(Up to 5 years)
  • Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20(Up to 5 years)
  • Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)(Up to 5 years)
  • Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5(Up to 5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (24)

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