A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Официальное название

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

Обзор

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)

Вмешательства

• Препарат Linvoseltamab
  Administered per the protocol
• Препарат Carfilzomib
  Administered per the protocol
• Препарат Daratumumab
  Administered per the protocol
• Препарат Dexamethasone
  Administered per the protocol
• Препарат Pomalidomide
  Administered per the protocol
• Препарат Bortezomib
  Administered per the protocol

Первичные конечные точки

• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 5 years]
• Severity of TEAEs [Срок оценки: Up to 5 years]
• Occurrence of Adverse Events of Special Interest (AESI) [Срок оценки: Up to 5 years]
• Severity of AESIs [Срок оценки: Up to 5 years]
• Occurrence of Serious Adverse Events (SAEs) [Срок оценки: Up to 5 years]
• Severity of SAEs [Срок оценки: Up to 5 years]
• Minimal Residual Disease (MRD)-negative Complete Response (CR) [Срок оценки: At 12 months]
• Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

• Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) [Срок оценки: Up to 28 days]
• Timing of grade ≥2 CRS [Срок оценки: Up to 28 days]
• Overall Survival (OS) [Срок оценки: Up to 7 years]
• Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC [Срок оценки: Up to 5 years]
• Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC [Срок оценки: Up to 5 years]
• Achievement of CR or better per IMWG response criteria as determined by BIRC [Срок оценки: Up to 5 years]
• Duration Of Response (DOR) as per IMWG response criteria [Срок оценки: Up to 5 years]
• Time To Progression (TTP) as per IMWG response criteria [Срок оценки: Up to 5 years]
• Time To Next Treatment (TTNT) [Срок оценки: Up to 5 years]
• Second PFS [Срок оценки: Up to 5 years]
• MRD-negative CR criteria at any time [Срок оценки: Up to 5 years]
• Time to PR IMWG response category [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

South Korea · 7 центров

• Chonnam National University Hwasun Hospital — Hwasun
• Seoul National University Hospital — Seoul
• Severance Hospital; Division of Hematology — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul
• Ulsan University Hospital — Ulsan

Великобритания · 6 центров

• Aberdeen Royal Infirmary — Aberdeen
• Royal Cornwall Hospital National Health Service (NHS) Foundation Trust — Truro
• University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology — Plymouth
• Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust — Norwich
• University Hospitals Birmingham NHS Trust, Center for Clinical — Birmingham
• Ninewells Hospital and Medical School — Dundee

США · 4 центра

• Emory Winship Cancer Institute — Atlanta
• Memorial Sloan Kettering Cancer Center — New York
• OhioHealth — Columbus
• University of Texas Health Science Center, Houston — Houston

Австралия · 3 центра

• Mater Misericordiae Ltd — Brisbane
• Gold Coast Hospital and Health Service — Southport
• Alfred Hospital — Melbourne

Идентификаторы

NCT: NCT07222761 · R5458-ONC-2246 · 2024-519504-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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