A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

Официальное название

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Обзор

This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma. The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM. 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)

Вмешательства

• Препарат Linvoseltamab
  Administered per the protocol
• Препарат Daratumumab
  Administered per the protocol

Первичные конечные точки

• Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria [Срок оценки: Up to 5 years]
• Biochemical PFS per IMWG criteria [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

• Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria [Срок оценки: Up to 3 years]
• Time to death [Срок оценки: Up to 9 years]
• Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria [Срок оценки: Up to 3 years]
• Best Overall Response (BOR) per IMWG criteria [Срок оценки: Up to 3 years]
• Achievement of MRD-negativity [Срок оценки: Up to 3 years]
• Sustained MRD-negativity [Срок оценки: Up to 3 years]
• Duration of MRD-negative CR [Срок оценки: Up to 3 years]
• Duration Of Response (DOR) per IMWG criteria [Срок оценки: Up to 5 years]
• Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to 3 years]
• Severity of TEAEs [Срок оценки: Up to 3 years]
• Occurrence of Serious Adverse Events (SAEs) [Срок оценки: Up to 3 years]
• Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scale [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group performance status score ≤1
• SMM diagnosis per IMWG criteria as defined in the protocol
• Meets HR-SMM criteria by 1 of the risk models as defined in the protocol

Критерии исключения

• Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol
• Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma
• History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder
• History of a seizure within the 12 months of randomization
• Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Emory University - Winship Cancer Institute — Atlanta
• Dana Farber / Harvard Cancer Center — Boston
• Karmanos Cancer Institute — Detroit

Идентификаторы

NCT: NCT07393282 · R5458-HM-24145 · 2025-523252-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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