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Подкожно в сравнении с изатуксимабом внутривенно в комбинации с помалидомидом и дексаметазоном при RRMM (IRAKLIA)

10 августа 2026 г. обновлено: Sanofi

Рандомизированное открытое исследование фазы 3 по оценке подкожного и внутривенного введения изатуксимаба в комбинации с помалидомидом и дексаметазоном у взрослых пациентов с рецидивирующей и/или рефрактерной множественной миеломой (RRMM)

Это рандомизированное многоцентровое открытое исследование фазы 3, в котором оценивается подкожное (п/к) и внутривенное (в/в) введение изатуксимаба в комбинации с помалидомидом и дексаметазоном (Pd) у пациентов с RRMM (участники исследования), которые ранее получали не менее 1 линия терапии, включающая леналидомид и ингибитор протеасом (ИП). Подходящие участники будут рандомизированы 1:1 в 1 из 2 групп исследования:

Группа п/к: изатуксимаб п/к + Pd

Группа IV: изатуксимаб IV + Pd

Участникам будет разрешено продолжать терапию до прогрессирования заболевания, неприемлемых нежелательных явлений (НЯ), запроса участника о прекращении терапии или любой другой причины, в зависимости от того, что наступит раньше.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

Две исследуемые группы будут проходить лечение в течение 4-недельных циклов до прогрессирования заболевания, неприемлемых нежелательных явлений (НЯ), запроса участника о прекращении терапии или любой другой причины, в зависимости от того, что наступит раньше.

Тип исследования

Интервенционный

Регистрация (Действительный)

531

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • New South Wales
      • Liverpool, New South Wales, Австралия, 2170
        • Investigational Site Number : 0360007
      • Waratah, New South Wales, Австралия, 2298
        • Investigational Site Number : 0360004
      • Wollongong, New South Wales, Австралия, 2500
        • Investigational Site Number : 0360003
    • South Australia
      • Adelaide, South Australia, Австралия, 5000
        • Investigational Site Number : 0360008
    • Victoria
      • Melbourne, Victoria, Австралия, 3004
        • Investigational Site Number : 0360006
      • Melbourne, Victoria, Австралия, 3065
        • Investigational Site Number : 0360009
      • Richmond, Victoria, Австралия, 3121
        • Investigational Site Number : 0360001
  • Аргентина
      • Buenos Aires, Аргентина, 1181
        • Investigational Site Number : 0320002
      • Buenos Aires, Аргентина, 1180
        • Investigational Site Number : 0320008
      • Buenos Aires, Аргентина, 1280
        • Investigational Site Number : 0320007
      • Buenos Aires, Аргентина, 1417
        • Investigational Site Number : 0320003
      • Buenos Aires, Аргентина, 1426
        • Investigational Site Number : 0320004
      • Buenos Aires, Аргентина, 1430
        • Investigational Site Number : 0320001
      • Buenos Aires, Аргентина, 1431
        • Investigational Site Number : 0320005
      • Córdoba, Аргентина, 5000
        • Investigational Site Number : 0320010
      • Mendoza, Аргентина, 5501
        • Investigational Site Number : 0320009
    • Buenos Aires
      • La Plata, Buenos Aires, Аргентина, 1900
        • Investigational Site Number : 0320006
  • Бразилия
      • Rio de Janeiro, Бразилия, 22775-001
        • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
      • São Paulo, Бразилия, 04537-080
        • Clinica São Germano- Site Number : 0760001
    • Ceará
      • Fortaleza, Ceará, Бразилия, 60115-280
        • Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
    • Pernambuco
      • Recife, Pernambuco, Бразилия, 51020-280
        • MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Бразилия, 90880-480
        • Hospital Mae de Deus- Site Number : 0760003
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Бразилия, 24020-096
        • CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
  • Венгрия
      • Budapest, Венгрия, 1097
        • Investigational Site Number : 3480004
      • Budapest, Венгрия, 1085
        • Investigational Site Number : 3480002
      • Kaposvár, Венгрия, 7400
        • Investigational Site Number : 3480003
      • Pécs, Венгрия, 7623
        • Investigational Site Number : 3480008
      • Szombathely, Венгрия, 9700
        • Investigational Site Number : 3480006
      • Székesfehérvár, Венгрия, 8000
        • Investigational Site Number : 3480005
  • Германия
      • Dresden, Германия, 01307
        • Investigational Site Number : 2760005
      • Heidelberg, Германия, 69120
        • Investigational Site Number : 2760003
      • Lübeck, Германия, 23562
        • Investigational Site Number : 2760006
      • Nuremberg, Германия, 90419
        • Investigational Site Number : 2760007
  • Греция
      • Athens, Греция, 106 76
        • Investigational Site Number : 3000002
      • Athens, Греция, 115 28
        • Investigational Site Number : 3000001
      • Pátrai, Греция, 265 04
        • Investigational Site Number : 3000003
      • Thessaloniki, Греция, 570 10
        • Investigational Site Number : 3000004
  • Испания
      • Madrid, Испания, 28034
        • Investigational Site Number : 7240005
      • Salamanca, Испания, 37007
        • Investigational Site Number : 7240002
    • Almería
      • Murcia, Almería, Испания, 30120
        • Investigational Site Number : 7240006
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Испания, 08916
        • Investigational Site Number : 7240004
    • Cantabria
      • Santander, Cantabria, Испания, 39008
        • Investigational Site Number : 7240003
    • Navarre
      • Pamplona, Navarre, Испания, 31008
        • Investigational Site Number : 7240001
  • Италия
      • Bologna, Италия, 40138
        • Investigational Site Number : 3800002
      • Brescia, Италия, 25123
        • Investigational Site Number : 3800005
      • Pavia, Италия, 27100
        • Investigational Site Number : 3800003
    • Ancona
      • Torette, Ancona, Италия, 60020
        • Investigational Site Number : 3800004
    • Reggio Emilia
      • Meldola, Reggio Emilia, Италия, 47014
        • Investigational Site Number : 3800001
    • Roma
      • Rome, Roma, Италия, 00168
        • Investigational Site Number : 3800006
  • Канада
    • Ontario
      • Toronto, Ontario, Канада, M5G 2M9
        • Investigational Site Number : 1240001
    • Quebec
      • Greenfield Park, Quebec, Канада, J4V 2H1
        • Investigational Site Number : 1240004
      • Montreal, Quebec, Канада, H1T 2M4
        • Investigational Site Number : 1240003
  • Китай
      • Beijing, Китай, 100191
        • Investigational Site Number : 1560022
      • Beijing, Китай, 100034
        • Investigational Site Number : 1560001
      • Changsha, Китай, 410013
        • Investigational Site Number : 1560010
      • Guangzhou, Китай, 510060
        • Investigational Site Number : 1560006
      • Hangzhou, Китай, 310003
        • Investigational Site Number : 1560002
      • Nanchang, Китай, 330006
        • Investigational Site Number : 1560020
      • Nanning, Китай, 530021
        • Investigational Site Number : 1560019
      • Qingdao, Китай, 266011
        • Investigational Site Number : 1560011
      • Shenyang, Китай, 110004
        • Investigational Site Number : 1560013
      • Tianjin, Китай, 300020
        • Investigational Site Number : 1560007
      • Tianjin, Китай, 300060
        • Investigational Site Number : 1560018
      • Tianjin, Китай, 300052
        • Investigational Site Number : 1560009
      • Wuhan, Китай, 430022
        • Investigational Site Number : 1560003
      • Wuhan, Китай, 430030
        • Investigational Site Number : 1560008
      • Zhengzhou, Китай, 450008
        • Investigational Site Number : 1560004
  • Норвегия
      • Oslo, Норвегия, 0450
        • Investigational Site Number : 5780001
      • Ålesund, Норвегия, 6017
        • Investigational Site Number : 5780002
  • Польша
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Польша, 31-501
        • Investigational Site Number : 6160005
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Польша, 50-088
        • Investigational Site Number : 6160004
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Польша, 20-081
        • Investigational Site Number : 6160001
  • Соединенное Королевство
    • Derbyshire
      • Derby, Derbyshire, Соединенное Королевство, DE22 3NE
        • Investigational Site Number : 8260003
    • England
      • Birmingham, England, Соединенное Королевство, B15 2TH
        • Investigational Site Number : 8260004
    • Leicestershire
      • Leicester, Leicestershire, Соединенное Королевство, LE1 5WW
        • Investigational Site Number : 8260002
    • London, City of
      • London, London, City of, Соединенное Королевство, W12 0HS
        • Investigational Site Number : 8260005
    • Norfolk
      • Norwich, Norfolk, Соединенное Королевство, NR4 7UY
        • Investigational Site Number : 8260001
  • Соединенные Штаты
    • Colorado
      • Aurora, Colorado, Соединенные Штаты, 80012
        • Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32224
        • Mayo Clinic in Florida- Site Number : 8400008
      • Plantation, Florida, Соединенные Штаты, 33322
        • Boca Raton Clinical Research Associates- Site Number : 8400030
    • Mississippi
      • Hattiesburg, Mississippi, Соединенные Штаты, 39401
        • Hattiesburg Clinic- Site Number : 8400006
    • New Jersey
      • Morristown, New Jersey, Соединенные Штаты, 07962
        • Atlantic Health System- Site Number : 8400005
    • New York
      • Albany, New York, Соединенные Штаты, 12206
        • New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
    • North Carolina
      • Charlotte, North Carolina, Соединенные Штаты, 28207
        • Novant Health Neurology & Sleep- Site Number : 8400014
    • Ohio
      • Canton, Ohio, Соединенные Штаты, 44718
        • Gabrail Cancer Center- Site Number : 8400027
      • Fairfield, Ohio, Соединенные Штаты, 45014
        • Oncology Hematology Care - Fairfield- Site Number : 8400016
    • South Carolina
      • Spartanburg, South Carolina, Соединенные Штаты, 29303
        • Spartanburg Regional Medical Center- Site Number : 8400002
    • Texas
      • Dallas, Texas, Соединенные Штаты, 75390
        • University of Texas - Southwestern Medical Center- Site Number : 8400024
      • San Antonio, Texas, Соединенные Штаты, 78240
        • Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84108
        • Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
  • Тайвань
      • Kaohsiung City, Тайвань, 833
        • Investigational Site Number : 1580001
      • Tainan, Тайвань, 704
        • Investigational Site Number : 1580005
      • Taipei, Тайвань, 100
        • Investigational Site Number : 1580002
  • Турция (Туркие)
      • Ankara, Турция (Туркие), 06010
        • Investigational Site Number : 7920007
      • Ankara, Турция (Туркие), 06200
        • Investigational Site Number : 7920009
      • Istanbul, Турция (Туркие), 34093
        • Investigational Site Number : 7920003
      • Istanbul, Турция (Туркие), 34098
        • Investigational Site Number : 7920005
      • Istanbul, Турция (Туркие), 34214
        • Investigational Site Number : 7920008
      • Istanbul, Турция (Туркие), 34381
        • Investigational Site Number : 7920001
      • Izmir, Турция (Туркие), 35100
        • Investigational Site Number : 7920004
  • Франция
      • Nantes, Франция, 44093
        • Investigational Site Number : 2500002
      • Paris, Франция, 75571
        • Investigational Site Number : 2500005
      • Poitiers, Франция, 86021
        • Investigational Site Number : 2500001
      • Saint-Priest-en-Jarez, Франция, 42270
        • Investigational Site Number : 2500009
      • Toulouse, Франция, 31059
        • Investigational Site Number : 2500003
      • Tours, Франция, 37032
        • Investigational Site Number : 2500007
  • Чехия
      • Brno, Чехия, 625 00
        • Investigational Site Number : 2030005
      • Olomouc, Чехия, 779 00
        • Investigational Site Number : 2030003
      • Ostrava, Чехия, 708 52
        • Investigational Site Number : 2030006
      • Prague, Чехия, 128 08
        • Investigational Site Number : 2030004
  • Чили
    • La Araucanía
      • Temuco, La Araucanía, Чили, 4780000
        • Investigational Site Number : 1520001
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Чили, 7580206
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Чили, 6900941
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Чили, 7620001
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana de Santiago, Чили, 8380455
        • Investigational Site Number : 1520004
    • Valparaiso
      • Viña del Mar, Valparaiso, Чили, 2540364
        • Investigational Site Number : 1520005
  • Швеция
      • Borås, Швеция, 501 82
        • Investigational Site Number : 7520001
      • Huddinge, Швеция, 141 57
        • Investigational Site Number : 7520003
  • Япония
      • Kyoto, Япония, 603-8151
        • Investigational Site Number : 3920003
      • Osaka, Япония, 530-8480
        • Investigational Site Number : 3920011
      • Tokyo, Япония, 150-8935
        • Investigational Site Number : 3920004
      • Yamagata, Япония, 990-9585
        • Investigational Site Number : 3920009
    • Aichi-ken
      • Nagoya, Aichi-ken, Япония, 467-8602
        • Investigational Site Number : 3920001
    • Chiba
      • Kamogawa, Chiba, Япония, 296-8602
        • Investigational Site Number : 3920007
    • Ibaraki
      • Higashiibaraki, Ibaraki, Япония, 311-3117
        • Investigational Site Number : 3920005
    • Iwate
      • Yahaba, Iwate, Япония, 028-3695
        • Investigational Site Number : 3920010
    • Kanagawa
      • Kamakura, Kanagawa, Япония, 247-8533
        • Investigational Site Number : 3920012
    • Okayama-ken
      • Okayama, Okayama-ken, Япония, 701-1192
        • Investigational Site Number : 3920002

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

  • Участники с множественной миеломой, получившие хотя бы одну предшествующую линию терапии, включающую леналидомид и ингибитор протеасом, и с измеримым уровнем М-белка в сыворотке (≥ 0,5 г/дл) и/или М-белком в моче (≥ 200 мг/24 часа) и/или анализ свободных легких цепей (СЛЦ) в сыворотке (анализ вовлеченных СЛЦ ≥10 мг/дл и аномальное соотношение СЛЦ в сыворотке (1,65))

Критерий исключения:

  • Участники младше 18 лет, участники со статусом производительности Восточной кооперативной онкологической группы более 2
  • Участники с первичной рефрактерной множественной миеломой
  • Участники, невосприимчивые к анти-CD38 с периодом вымывания менее 9 месяцев или непереносимые к агентам mAb против CD38
  • Предшествующая терапия помалидомидом
  • Участники с неадекватными биологическими тестами.
  • Значительная сердечная дисфункция
  • Участники, у которых был диагностирован или лечился другой рак в течение 3 лет до рандомизации, за исключением полной резекции базально-клеточной карциномы или плоскоклеточного рака кожи, а также злокачественных новообразований in situ или рака предстательной железы низкого риска после лечебной терапии.
  • Сопутствующий плазмоклеточный лейкоз
  • Активный первичный амилоидно-легкий (AL) амилоидоз
  • Известное заболевание, связанное с синдромом приобретенного иммунодефицита (СПИД), или известное заболевание, вызванное вирусом иммунодефицита человека (ВИЧ), требующее противовирусного лечения
  • Знайте активную инфекцию гепатита А. Текущая активная или хроническая инфекция гепатита В (ВГВ) или гепатита С (ВГС). Допускаются участники с хроническим заболеванием ВГВ или ВГС, контролируемым противовирусной терапией.
  • Женщины детородного возраста или мужчины-участники с женщинами детородного возраста, которые не согласны использовать высокоэффективный метод контроля над рождаемостью

Приведенная выше информация не предназначена для того, чтобы содержать все соображения, относящиеся к потенциальному участию участника в клиническом исследовании.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Исатуксимаб внутривенно (IV)
Дозу исатуксимаба будут вводить внутривенно еженедельно в течение 4 недель в течение цикла 1 (дни 1, 8, 15 и 22), а также в дни 1 и 15 последующих циклов. Каждый цикл будет длиться 28 дней. Дозу помалидомида будут принимать перорально с 1 по 21 день каждого цикла в наиболее удобное для участников время до или после введения изатуксимаба, предпочтительно в одно и то же время каждый день. Дексаметазон будет приниматься перорально в 1, 8, 15 и 22 дни (повторять каждые 28 дней). Участники могут получать другие виды лечения в качестве фонового лечения и/или препаратов экстренной помощи.
Лекарство: Дексаметазон
Лекарственная форма: Таблетка; Путь введения: пероральный
Лекарство: Помалидомид
Лекарственная форма: твердые капсулы; Путь введения: пероральный
Другие имена:
  • Помалист или эквивалент
Лекарство: Изатуксимаб внутривенно
Лекарственная форма: раствор-концентрат для в/в инфузий; Путь введения: Внутривенно
Другие имена:
  • 650984 юаней
  • САРКЛИЗА®
Лекарство: Дексаметазон
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; Вспомогательный лекарственный препарат (AxMP), т.е. фоновое лечение; Код АТС: H02AB02
Лекарство: Монтелукаст
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; AxMP, т.е. фоновое лечение; Код АТС: R03DC03
Лекарство: Парацетамол/ацетаминофен
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; AxMP, т.е. фоновое лечение; Код АТС: N02BE01
Лекарство: Димедрол
Лекарственная форма: Согласно местному коммерческому продукту; Способ применения: В качестве премедикации – перорально; для лечения инфузионных реакций-IV (или перорального эквивалента); AxMP, т.е. фоновое лечение и препараты экстренной помощи (в случае инфузионных реакций); Код АТС: R06AA02
Лекарство: Метилпреднизолон
Лекарственная форма: Согласно местному коммерческому продукту; Способ применения: В качестве премедикации-IV; для лечения инфузионных реакций – внутривенно (или пероральный эквивалент); AxMP, т.е. фоновое лечение и препараты экстренной помощи (в случае инфузионных реакций); Код АТС: H02AB04
Экспериментальный: Isatuximab Subcutaneous (SC)
Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Лекарство: Изатуксимаб п/к
Лекарственная форма: Раствор для подкожного введения; Путь введения: Подкожный (п/к)
Другие имена:
  • 650984 юаней
Лекарство: Дексаметазон
Лекарственная форма: Таблетка; Путь введения: пероральный
Лекарство: Помалидомид
Лекарственная форма: твердые капсулы; Путь введения: пероральный
Другие имена:
  • Помалист или эквивалент
Лекарство: Дексаметазон
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; Вспомогательный лекарственный препарат (AxMP), т.е. фоновое лечение; Код АТС: H02AB02
Лекарство: Монтелукаст
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; AxMP, т.е. фоновое лечение; Код АТС: R03DC03
Лекарство: Парацетамол/ацетаминофен
Лекарственная форма: Согласно местному коммерческому продукту; Путь применения: Перорально; AxMP, т.е. фоновое лечение; Код АТС: N02BE01
Лекарство: Димедрол
Лекарственная форма: Согласно местному коммерческому продукту; Способ применения: В качестве премедикации – перорально; для лечения инфузионных реакций-IV (или перорального эквивалента); AxMP, т.е. фоновое лечение и препараты экстренной помощи (в случае инфузионных реакций); Код АТС: R06AA02
Лекарство: Метилпреднизолон
Лекарственная форма: Согласно местному коммерческому продукту; Способ применения: В качестве премедикации-IV; для лечения инфузионных реакций – внутривенно (или пероральный эквивалент); AxMP, т.е. фоновое лечение и препараты экстренной помощи (в случае инфузионных реакций); Код АТС: H02AB04

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Общий показатель ответа (ОРР)
Временное ограничение: С момента первого введения исследуемого препарата (День 1) до ПКД (06-ноя-2024), приблизительно 28 месяцев
ORR по оценке независимого комитета (IRC) с использованием критериев международной рабочей группы по миеломе (IMWG) 2016 года: Процент участников с полным ответом (CR), строгим полным ответом (sCR), очень хорошим частичным ответом (VGPR) и частичным ответом (PR). CR: отрицательная иммунофиксация в сыворотке и моче, исчезновение любых плазмоцитом мягких тканей (STP), <5% плазматических клеток в аспиратах костного мозга (BM) и нормальное соотношение свободных легких цепей (FLC) (0,26-1,65). sCR: CR плюс отсутствие клональных клеток в биопсии костного мозга. VGPR: М-белок в сыворотке и моче обнаруживается иммунофиксацией, но не электрофорезом; снижение М-белка в сыворотке ≥90% плюс уровень М-белка в моче <100 мг/24 часа; снижение суммы максимальных перпендикулярных диаметров (SPD) по сравнению с исходным уровнем в STP ≥90%; только FLC: снижение разницы между вовлеченными и невовлеченными уровнями FLC ≥90%. PR: снижение М-белка в сыворотке ≥50% и снижение М-белка в моче за 24 часа ≥90% или до <200 мг/24 часа. В дополнение к вышеуказанному, если присутствовало на исходном уровне, также требуется снижение размера SPD STP ≥50%.
С момента первого введения исследуемого препарата (День 1) до ПКД (06-ноя-2024), приблизительно 28 месяцев
Наблюдаемая концентрация изатуксимаба перед введением дозы (Ctrough) в установившемся состоянии
Временное ограничение: Предварительная доза на 6-м цикле, день 1
Ctrough в устойчивом состоянии представлял собой наблюдаемую концентрацию в плазме, взятую перед введением дозы на 1 день Цикла 6 (эквивалентно периоду до 1 дня Цикла 6) введения исатуксимаба.
Предварительная доза на 6-м цикле, день 1

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Корытная концентрация изатуксимаба через 4 недели (КК4Н)
Временное ограничение: Перед введением дозы на Цикл 2 День 1 (через 4 недели)
Концентрации CT4W были наблюдаемыми концентрациями в плазме, собранными до введения дозы перед началом Цикла 2 День 1 (эквивалентно до Цикла 2 День 1) введения дозы изатуксимаба.
Перед введением дозы на Цикл 2 День 1 (через 4 недели)
Процент участников, ответивших «Очень доволен» и «Доволен» в опроснике «Опыт и удовлетворенность пациента (PESQ-FU)»: Удовлетворенность методом инъекции (пункт 8) на 15 день 5 цикла
Временное ограничение: Цикл 5 День 15
Опросник PESQ-FU, состоящий из 9 пунктов, был разработан для отслеживания опыта и удовлетворенности участников относительно метода инъекции (дискомфорт, боль, побочные эффекты, экономия времени и удовлетворенность) и исследуемого препарата (побочные эффекты, целесообразность приема, удовлетворенность и рекомендация). Данный опросник был адаптирован на основе качественных интервью с онкологическими участниками. Ответы на вопрос 'удовлетворенность методом инъекции' регистрировались как 'очень удовлетворен, удовлетворен, ни удовлетворен, ни неудовлетворен, неудовлетворен и очень неудовлетворен' в установленные временные точки. Общий процент участников, которые были очень удовлетворены и удовлетворены методом инъекции (пункт-8) на 15 день 5 цикла, представлен здесь. Проценты округлены до десятого знака после запятой.
Цикл 5 День 15
Минимальная концентрация изатуксимаба
Временное ограничение: Перед приемом препарата в 1 цикле в дни 8, 15 и 22, в циклах 2-5 в дни 1 и 15, в циклах 6, 7, 8, 9, 12, 15, 18, 21, 24 и 27 в день 1
Плазменные образцы были собраны в установленные моменты времени для оценки Cmin.
Перед приемом препарата в 1 цикле в дни 8, 15 и 22, в циклах 2-5 в дни 1 и 15, в циклах 6, 7, 8, 9, 12, 15, 18, 21, 24 и 27 в день 1
Процент участников с ответом на 'Опросник ожиданий пациента на исходном уровне (PEQ-BL)'
Временное ограничение: Исходный уровень (Цикл 1 День 1)
Сообщается процент участников, которые на исходном уровне ответили, что полностью согласны или согласны с ожиданиями относительно боли, дискомфорта и побочных эффектов от метода инъекции, что метод инъекции сэкономит время, что исследуемый препарат может вызвать побочные эффекты и что его стоит принимать. Опросник ожиданий пациента на исходном уровне (PEQ-BL) состоял из 7 пунктов. Также сообщается процент участников, которые когда-либо получали лекарство путем внутривенного и/или подкожного введения. Проценты округлены до десятого знака после запятой. Исходное значение определялось как последнее имеющееся значение, собранное в дату начала приема исследуемого препарата или до нее.
Исходный уровень (Цикл 1 День 1)
Анкета использования медицинских ресурсов и производительности (HRUPQ): Исходное использование медицинской помощи: Количество раз за последние 6 месяцев, когда участник получал медицинскую помощь
Временное ограничение: Базовый уровень (Цикл 1 День 1)
Использование медицинской помощи на исходном уровне до введения исследуемого препарата собиралось с помощью HRUPQ. Представлено среднее количество раз за последние 6 месяцев, когда участник получал помощь в клинике или отделении неотложной помощи больницы по любой проблеме со здоровьем, включая ММ или из-за ММ, и помощь на дому от медсестры или другого медицинского работника по любой проблеме со здоровьем, включая ММ или из-за ММ. Исходное значение определялось как последнее присутствующее значение, собранное в дату начала приема исследуемого препарата или до нее.
Базовый уровень (Цикл 1 День 1)
HRUPQ: Базовое использование медицинских услуг: Количество ночей, проведенных участником в больнице за последние 6 месяцев
Временное ограничение: Базовый уровень (Цикл 1 День 1)
Использование медицинской помощи на исходном уровне до введения исследуемого препарата собиралось с помощью HRUPQ. Представлено среднее количество ночей за последние 6 месяцев, которое участник провел в больнице по любой проблеме со здоровьем, включая ММ или из-за ММ, и провел в отделении интенсивной терапии (ОИТ) по любой проблеме со здоровьем, включая ММ или из-за ММ. Исходное значение определялось как последнее имеющееся значение, собранное до даты начала приема исследуемого препарата или в эту дату.
Базовый уровень (Цикл 1 День 1)
HRUPQ: Исходное использование медицинских услуг: количество обращений участника к медицинскому работнику за последние 6 месяцев
Временное ограничение: Базовый уровень (Цикл 1 День 1)
Использование медицинской помощи на исходном уровне до введения исследуемого препарата собиралось с помощью HRUPQ. Представлено среднее количество раз за последние 6 месяцев, когда участник консультировался (виделся или разговаривал) со следующими медицинскими работниками: врачом общей практики или врачом первичной медико-санитарной помощи (PCC), который лечит различные заболевания по любой проблеме со здоровьем, включая ММ или связанную с ММ, физиотерапевтом или эрготерапевтом по любой проблеме со здоровьем, включая ММ или связанную с ММ, специалистом в области психического здоровья (например, психиатром, психологом, психиатрической медсестрой) по любой проблеме со здоровьем, включая ММ или связанную с ММ, врачом или клиницистом, который специализируется на конкретном медицинском заболевании или проблеме (специалистом) по любой проблеме со здоровьем, включая ММ или связанную с ММ. Исходное значение определялось как последнее присутствующее значение, собранное в дату начала приема исследуемого препарата или до нее.
Базовый уровень (Цикл 1 День 1)
Процент участников, которые когда-либо уходили на пенсию в ходе исследования на основе HRUPQ
Временное ограничение: С первой дозы исследуемого препарата (День 1) до ПКО (06-ноя-2024), приблизительно 28 месяцев
Статус занятости оценивался с помощью HRUPQ. Сообщается процент участников, которые когда-либо вышли на пенсию в ходе исследования. Проценты округляются до десятого знака после запятой.
С первой дозы исследуемого препарата (День 1) до ПКО (06-ноя-2024), приблизительно 28 месяцев
Процент участников, досрочно вышедших на пенсию из-за ММ на основе HRUPQ
Временное ограничение: С первой дозы исследуемого препарата (День 1) до ПКД (06-ноя-2024), приблизительно 28 месяцев
Статус занятости оценивался с помощью HRUPQ. Процент участников, вышедших на пенсию досрочно из-за ММ, указан в отчете. Проценты округлены до десятого знака после запятой.
С первой дозы исследуемого препарата (День 1) до ПКД (06-ноя-2024), приблизительно 28 месяцев
Very Good Partial Response or Better Rate
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, <5% plasma cells in BM aspirates & normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24h;>=90% decrease in SPD compared to baseline in STP; FLC only:>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants With Infusion Reactions
Временное ограничение: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged [not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Duration of Response (DOR)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]),serum M-protein increase>=1g/dL if lowest M-component >=5g/dL, urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis. PR: as defined in OM1.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to First Response (TT1R)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline, >=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to Best Response (TTBR)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline,>=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression-free Survival (PFS)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS was defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses were determined according to IMWG criteria. PFS was censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever came first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Overall Survival (OS)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
OS was defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever was first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression Free Survival 2 (PFS2)
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS2 was defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happened first. Same censoring rule applies as in the PFS endpoint.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
Временное ограничение: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Временное ограничение: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints. Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
Временное ограничение: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants. In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV). Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here. Percentages are rounded off to the tenth decimal place.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
Временное ограничение: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
Временное ограничение: From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Временное ограничение: Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Role Functioning
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Social Functioning
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Fatigue
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Pain
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Dyspnea
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Insomnia
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Constipation
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Diarrhea
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Body Image
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Временное ограничение: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
ORR Based on at Least 1 Chromosomal Abnormality
Временное ограничение: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
BM aspirate was collected for fluorescent in situ hybridization for analysis of del[17p], t[4;14], t[14;16]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. [del(17p)] or [1q21+ and t(4;14) or t(14;16)] is presented. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months

Соавторы и исследователи

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Спонсор

Sanofi

Следователи

  • Директор по исследованиям: Clinical Sciences & Operations, Sanofi

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

23 июня 2022 г.

Первичное завершение (Действительный)

6 ноября 2024 г.

Завершение исследования (Оцененный)

22 октября 2027 г.

Даты регистрации исследования

Первый отправленный

31 мая 2022 г.

Впервые представлено, что соответствует критериям контроля качества

31 мая 2022 г.

Первый опубликованный (Действительный)

6 июня 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

2 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EFC15951
  • 2023 (Грант/контракт NIH США: GRAMMY Museum Foundation)
  • U1111-1261-5846 (Идентификатор реестра: ICTRP)
  • 2023-508869-32 (Номер EudraCT: CTIS)

Планирование данных отдельных участников (IPD)

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ДА

Описание плана IPD

Квалифицированные исследователи могут запросить доступ к данным на уровне пациентов и связанным с ними документам исследования, включая отчет о клиническом исследовании, протокол исследования с любыми поправками, пустую форму отчета о случае, план статистического анализа и спецификации набора данных. Данные на уровне пациентов будут анонимизированы, а документы исследования будут отредактированы для защиты конфиденциальности участников исследования. Дополнительную информацию о критериях обмена данными Санофи, приемлемых исследованиях и процессе запроса доступа можно найти по адресу: https://vivli.org.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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