A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Официальное название

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

Обзор

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Вмешательства

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

Первичные конечные точки

• Minimal Residual Disease (MRD) [Срок оценки: up to 11 years]
• MRD negative CR status by BICR [Срок оценки: up to 11 years]
• Progression Free Survival (PFS) per IMWG criteria [Срок оценки: up to 11 years]
• PFS as determined by BICR [Срок оценки: up to 11 years]

Вторичные конечные точки (12)

• Overall Survival (OS) [Срок оценки: up to 11 years]
• Objective Response (OR) of Complete Response (CR) [Срок оценки: up to 11 years]
• OR of Very Good Partial Response (VGPR) [Срок оценки: up to 11 years]
• OR of Partial Response (PR) [Срок оценки: up to 11 years]
• Sustained MRD [Срок оценки: up to 11 years]
• Duration of response (DOR) of stringent (s)CR [Срок оценки: up to 11 years]
• Duration of response (DOR) of CR [Срок оценки: up to 11 years]
• Duration of response (DOR) of VGPR [Срок оценки: up to 11 years]
• Duration of response (DOR) of PR [Срок оценки: up to 11 years]
• Time to response ≥CR [Срок оценки: up to 11 years]
• Time to response ≥VGPR [Срок оценки: up to 11 years]
• Time to response ≥PR [Срок оценки: up to 11 years]

Критерии участия

Критерии включения

• Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
• Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
• Participants must have measurable disease as defined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Participants must have clinical laboratory values within a prespecified range.

Критерии исключения

• International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
• Participants who defer transplant due to personal preference.
• Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
• Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of:

• focal radiation and/or
• a short course of corticosteroids as defined in the protocol.
• Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM
• 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), stroke or seizure within 12 months prior to study C1D1.
• Participants who have uncontrolled intercurrent illness.
• Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.

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

Италия · 11 центров

• AOU Ospedali Riuniti di Ancona — Ancona
• Azienda Ospedaliera Santa Croce e Carle - Ematologia — Cuneo
• A.O.U. Careggi — Florence
• IRCCS Ospedale Policlinico San Martino — Genova
• Ospedale di Legnano, ASST Ovest Milanese — Legnano
• Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) — Meldola
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia — Milan
• … и ещё 3 центра

Австралия · 8 центров

• Flinders Medical Centre — Adelaide
• Box Hill Hospital — Box Hill
• Canberra Hospital — Canberra
• Barwon Health, University Hospital Geelong — Geelong
• Austin Hospital — Heidelberg
• Nepean Cancer Centre — Kingswood
• Northern Hospital — Melbourne
• Sunshine Coast Health — Sunshine Coast

Испания · 5 центров

• Institut Catala D'oncologia (Badalona) — Badalona
• Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit — Barcelona
• Hospital Quirón Salud Madrid — Madrid
• Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service — Santander
• Hospital Universitario la Fe, Valencia — Valencia

Чехия · 4 центра

• Fakultni Nemocnice Hradec Kralove — Hradec Králové
• University Hospital Olomouc — Olomouc
• Fakultni Nemocnice Ostrava — Ostrava
• Fakultni Nemocnice Plzen — Pilsen

Греция · 4 центра

• University Hospital of Alexandroupolis — Alexandroupoli
• Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens — Athens
• Evaggelismos Hospital — Athens
• Theagenion Cancer Hospital — Thessaloniki

Turkey (Türkiye) · 4 центра

• Ankara University Faculty of Medicine, Department of Hematology — Ankara
• Liv Hospital Ankara — Ankara
• Ege Universitesi Tip Fakultesi - Hematology — Izmir
• Ege University Medicine Faculty, Izmir — Izmir

Германия · 3 центра

• Universitaetsmedizin Greifswald — Greifswald
• Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und On — Lübeck
• University Hospital of Würzburg — Würzburg

Ирландия · 3 центра

• Cork University Hospital — Cork
• Beaumont Hospital — Dublin
• University Hospital Limerick - Department of Haematology — Limerick

Норвегия · 3 центра

• Stavanger University Hospital — Stavanger
• St. Olavs hospital HF — Trondheim
• Vestfold Hospital Trust — Tønsberg

Австрия · 2 центра

• Ordensklinikum Linz — Linz
• Klinik Ottakring — Vienna

Эстония · 2 центра

• North Estonia Medical Centre Foundation — Tallinn
• Tartu University Hospital — Tartu

Финляндия · 2 центра

• Helsinki University Hospital Comprehensive Cancer Center — Helsinki
• Kuopio University Hospital — Kuopio

Португалия · 2 центра

• CHUC — Coimbra
• Hospital da Luz Lisboa — Lisbon

Швейцария · 2 центра

• Universitaetsspital Basel - Zentrum fur Hamato-Onkologie — Basel
• Kantonsspital St. Gallen — Sankt Gallen

Хорватия · 1 центр

• University Hospital Centre Zagreb - Clinic for Internal Medicine — Zagreb

Дания · 1 центр

• Aarhus Universitetshospital — Aarhus

Нидерланды · 1 центр

• Erasmus MC — Rotterdam

Швеция · 1 центр

• Skåne University Hospital, Region Skåne — Lund

Идентификаторы

NCT: NCT06932562 · EMN39 · 2024-519827-16-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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