临床试验/NCT07428369

NCT07428369撤回2 期

A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple Myeloma

Regeneron Pharmaceuticals0 个研究点目标入组 1,570 人开始时间: 2026年6月5日最近更新: 2026年6月18日

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: Regeneron Pharmaceuticals
入组人数: 1,570
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记录与标识符相似试验

研究概览

简要总结

This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT).

This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR.

The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments.

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

What side effects may happen from taking linvoseltamab
How much linvoseltamab is in the blood at different times
Whether the body makes antibodies against the linvoseltamab (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

•Participants must have a histologically or cytologically confirmed diagnosis of multiple myeloma, which requires the presence of clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma, and at least one other criteria as defined by the SLiM (>=60%, Light chains I/U >10, Magnetic resonance imaging >1 focal lesion) CRAB (Calcium elevation, Renal insufficiency, Anemia, Bone disease) criteria
•Participants must have measurable disease, as defined in the protocol
•Participants must be considered eligible for high-dose chemotherapy (melphalan) and ASCT per local standard guidelines
•Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•Must be willing to defer ASCT

排除标准

•Any prior therapy for Monoclonal Gammopathy of Undetermined Significance (MGUS), Monoclonal Gammopathy of Renal Significance (MGRS), Smoldering Multiple Myeloma (SMM), or MM, with the exception of those defined in the protocol
•Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM (or another plasma cell disorder), or those whose AEs due to agents administered earlier (such as radiation and/or corticosteroids) have not recovered to a severity of grade 0 or grade 1
•Participants with non-secretory MM, diagnosis of plasma cell leukemia (>20% circulating plasma cells), symptomatic amyloidosis (including myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes).
•Participants who have known Central Nervous System (CNS) or meningeal involvement with MM or known or suspected Progressive Multifocal Leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, Transient Ischemic Attack (TIA), or stroke within 12 months prior to study randomization
•Another malignancy besides MM that is progressive or has required treatment in the 3 years preceding randomization with the exceptions defined in the protocol
•NOTE: Other protocol defined inclusion/exclusion criteria apply

干预措施: Bortezomib (Drug)

结局指标

主要结局

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

时间窗: Up to day 112

Phase 2

Severity of TEAEs

时间窗: Up to day 112

Phase 2

Achievement of Complete Response or better (≥CR) per International Myeloma Working Group (IMWG) criteria

时间窗: Up to day 112

Phase 2

Minimal Residual Disease (MRD) negative CR at 10^-5 per IMWG criteria

时间窗: Up to 12 months

Phase 3

Progression Free Survival (PFS) per IMWG

时间窗: Up to 5 years

Phase 3

次要结局

Occurrence of TEAEs(Up to 3.5 years)
Severity of TEAEs(Up to 3.5 years)
Occurrence of Serious Adverse Events (SAEs)(Up to 3.5 years)
Severity of SAEs(Up to 3.5 years)
Occurrence of Cytokine Release Syndrome (CRS)(Up to day 30)
Severity of CRS(Up to day 30)
Occurrence of Cell-Associated Neurotoxicity Syndrome (ICANS)(Up to day 30)
Severity of ICANS(Up to day 30)
Achievement of objective response [Partial Response or better (≥PR)] per IMWG criteria(Up to 5 years)
Time to ≥PR per IMWG criteria(Up to 5 years)
Time to Very Good Partial Response or better (≥VGPR) per IMWG criteria(Up to 5 years)
Time to ≥CR per IMWG criteria(Up to 5 years)
Achievement of MRD negative (at 10^-5 sensitivity) CR per IMWG criteria(Up to 5 years)
Duration Of Response (DOR) of ≥PR per IMWG criteria(Up to 5 years)
Duration of ≥VGPR per IMWG criteria(Up to 5 years)
Duration of ≥CR per IMWG criteria(Up to 5 years)
PFS per IMWG criteria(Up to 5 years)
Second PFS (PFS2) per IMWG criteria(Up to 5 years)
Overall Survival (OS)(Up to 5 years)
Concentrations of total linvoseltamab in serum(Up to 5 years)
Occurrence of TEAEs(Up to 5 years)
Severity of TEAEs(Up to 5 years)
Occurrence of SAEs(Up to 5 years)
Severity of SAEs(Up to 5 years)
Occurrence of second primary malignancies(Up to 5 years)
Time to definitive deterioration in GHS per EORTC QLQ-C30(Up to 5 years)
Time to definitive deterioration in physical functioning per EORTC QLQ-C30(Up to 5 years)
Time to definitive deterioration in role functioning per EORTC QLQ-C30(Up to 5 years)
Time to definitive deterioration in pain per EORTC QLQ-C30(Up to 5 years)
Time to definitive deterioration in fatigue per EORTC QLQ-C30(Up to 5 years)
Time to definitive deterioration in disease symptoms per EORTC QLQ-MY20(Up to 5 years)
Time to definitive deterioration in treatment side effects per EORTC QLQ-MY20(Up to 5 years)
Time to definitive deterioration in body image per EORTC QLQ-MY20(Up to 5 years)
Time to definitive deterioration in future perspective per EORTC QLQ-MY20(Up to 5 years)
Time to definitive deterioration in EQ-5D-5L VAS(Up to 5 years)
Time to first improvement in GHS per EORTC QLQ-C30(Up to 5 years)
Time to first improvement in physical functioning per EORTC QLQ-C30(Up to 5 years)
Time to first improvement in role functioning per EORTC QLQ-C30(Up to 5 years)
Time to first improvement in pain per EORTC QLQ-C30(Up to 5 years)
Time to first improvement in fatigue per EORTC QLQ-C30(Up to 5 years)
Time to first improvement in disease symptoms per EORTC QLQ-MY20(Up to 5 years)
Time to first improvement in treatment side effects per EORTC QLQ-MY20(Up to 5 years)
Time to first improvement in body image per EORTC QLQ-MY20(Up to 5 years)
Time to first improvement in future perspective per EORTC QLQ-MY20(Up to 5 years)
Time to first improvement in EQ-5D-5L VAS(Up to 5 years)
Proportion with clinically meaningful improvement in GHS per EORTC QLQ-C30(Up to 5 years)
Proportion with clinically meaningful improvement in physical functioning per EORTC QLQ-C30(Up to 5 years)
Proportion with clinically meaningful improvement in role functioning per EORTC QLQ-C30(Up to 5 years)
Proportion with clinically meaningful improvement in pain per EORTC QLQ-C30(Up to 5 years)
Proportion with clinically meaningful improvement in fatigue per EORTC QLQ-C30(Up to 5 years)
Proportion with clinically meaningful improvement in disease symptoms per EORTC QLQ-MY20(Up to 5 years)
Proportion with clinically meaningful improvement in treatment side effects per EORTC QLQ-MY20(Up to 5 years)
Proportion with clinically meaningful improvement in body image per EORTC QLQ-MY20(Up to 5 years)
Proportion with clinically meaningful improvement in future perspective per EORTC QLQ-MY20(Up to 5 years)
Proportion of clinically meaningful improvement in EQ-5D-5L VAS(Up to 5 years)
Proportion of patients with high side effect bother as measured by FACIT- Item GP5(Up to 5 years)
Change from baseline in disease symptoms per EORTC QLQ- Multiple Myeloma Module 20 (MY20)(Up to 5 years)
Change from baseline in Global Health Status (GHS) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30)(Up to 5 years)
Change from baseline in physical functioning per EORTC QLQ-C30(Up to 5 years)
Change from baseline in role functioning 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 from baseline in treatment side effects per EORTC QLQ-MY20(Up to 5 years)
Change from baseline in body image per EORTC QLQ-MY20(Up to 5 years)
Change from baseline in future perspective per EORTC QLQ-MY20(Up to 5 years)
Change from baseline in EuroQoL-5 Dimensions 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)(Up to 5 years)
Mean proportion of time with high side effect bother as measured by Functional Assessment of Cancer Therapy (FACIT)- Item Global Population 5 (GP5)(Up to 5 years)
Occurrence of Anti-Drug Antibody (ADA) to linvoseltamab in serum(Up to 5 years)
Magnitude of ADA to linvoseltamab in serum(Up to 5 years)

研究者

发起方

Regeneron Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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