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Идёт набор NCT07094048

Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager

Фаза IV С лечением Multiple Myeloma Refractory Relapsed Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Target trough IgG level of 8-10 g/L, Target trough IgG level 4-6 g/L, No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L.
Кому может быть актуально
Состояния в реестре: Multiple Myeloma Refractory, Relapsed Multiple Myeloma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Bispecific antibody therapies targeting BCMA (B-cell maturation antigen) represent a novel therapeutic approach for patients with multiple myeloma. They are currently used in cases of refractory multiple myeloma but are also being investigated in earlier lines of treatment. However, these new therapies can lead to deeper immunosuppression and exacerbate an underlying immunosuppressive state in patients with multiple myeloma. As a result, infectious complications are common with these therapies and are a significant concern. Therefore, preventing infections in this population is crucial. However, data on the best strategies for prevention are currently lacking.

Подробное описание

Although the effectiveness of immunoglobulins (Ig) has been demonstrated, it remains to be determined whether immunoglobulin administration is necessary for all patients receiving these therapies or only for those with low serum immunoglobulin G (IgG) levels. Furthermore, the optimal target IgG level to achieve in order to reduce the risk of infections is also unknown in this specific population of multiple myeloma patients. Guidance needs to be provided to the clinicians to better support MM patients undergoing this novel therapy by addressing the hypogammaglobulinemia and therefore limiting and ideally avoiding the high risk of infections.

In this prospective, randomized, unblinded, multicenter study, as per the standard of care approach, every patient with relapsed refractory MM receiving a BCMA-directed TCE with history of recurrent or severe infections and/or total IgG level less than 4 g/L will receive Ig support (intravenous ou subcutaneous). Once on Ig supplementation, the optimal target trough IgG level to achieve is not well established. The goal of this study is therefore to better define, in this patient population , the target trough IgG level to achieve a reduction in the incidence of severe infections.

The primary objective is to demonstrate the non-inferiority in the cumulative incidence of severe infections at 3 months between patients on Ig support with a target trough IgG level of 4-6 g/L (experimental group) versus a target trough IgG level of 8-10 g/L (standard of care (SOC) group).

Вмешательства

  • Препарат Target trough IgG level of 8-10 g/L
    Target trough IgG level of 8-10 g/L
  • Препарат Target trough IgG level 4-6 g/L
    Target trough IgG level of 4-6 g/L
  • Препарат No history of recurrent or severe infections and total IgG level higher or equal at 4 g/L
    If, during follow-up, the patient presents recurrent or severe infections and/or total IgG level less 4 g/L, crossover to group A or B

Первичные конечные точки

  • Severe infections [Срок оценки: From enrollment to 3 months after time of randomization]
Вторичные конечные точки (2)
  • Minor/Moderate infections rate [Срок оценки: From enrollment to 12 monts after randomization]
  • All infection rate [Срок оценки: From enrollment to 12 months after randomization]

Критерии участия

Критерии включения

  • Multiple myeloma patient:
  • ≥ 18 years old
  • ≥ 1 prior lines of therapy
  • Receiving a BCMA-directed T-cell Engager therapy (starting on treatment)
  • On previous Ig support or not

Критерии исключения

  • Less than 18 years old
  • Pregancy or breastfeeding

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

Канада · 2 центра
  • Santé Québec Chaudière-Appalaches — Lévis
  • Centre Intégré de Cancérologie — Québec

Публикации

  • Mohan M, Monge J, Shah N, Luan D, Forsberg M, Bhatlapenumarthi V, Balev M, Patwari A, Cheruvalath H, Bhutani D, Thanendrarajan S, Dhakal B, Zangari M, Al-Hadidi S, Cooper D, Lentzsch S, van Rhee F, D'Souza A, Szabo A, Schinke C, Chakraborty R. Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study. Blood Cancer J. 2024 Mar 5;14(1):35. doi: 10.1038/s41408-024-0100 PMID 38443345
  • Compagno N, Cinetto F, Semenzato G, Agostini C. Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients. Haematologica. 2014 Jun;99(6):1101-6. doi: 10.3324/haematol.2013.101261. Epub 2014 Mar 28. PMID 24682509
  • Gardulf A, Nicolay U, Math D, Asensio O, Bernatowska E, Bock A, Costa-Carvalho BT, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Matamoros N, Niehues T, Schmidt S, Schulze I, Borte M. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004 Oct;114(4):936-42. doi: 10.1016/j.jaci.2004.06.053. PMID 15480339
  • Ducruet T, Levasseur MC, Des Roches A, Kafal A, Dicaire R, Haddad E. Pharmacoeconomic advantages of subcutaneous versus intravenous immunoglobulin treatment in a Canadian pediatric center. J Allergy Clin Immunol. 2013 Feb;131(2):585-7.e1-3. doi: 10.1016/j.jaci.2012.08.022. Epub 2012 Oct 2. No abstract available. PMID 23040368
  • Martin A, Lavoie L, Goetghebeur M, Schellenberg R. Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfus Med. 2013 Feb;23(1):55-60. doi: 10.1111/j.1365-3148.2012.01201.x. Epub 2012 Nov 20. PMID 23167310
  • Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, El-Gamal Y, Harville TO, Hossny E, Mazer B, Nelson R, Secord E, Jordan SC, Stiehm ER, Vo AA, Ballow M. Update on the use of immunoglobulin in human disease: A review of evidence. J Allergy Clin Immunol. 2017 Mar;139(3S):S1-S46. doi: 10.1016/j.jaci.2016.09.023. Epub 2016 Dec 29. PMID 28041678
  • Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. doi: 10.2165/00063030-200721020-00005. PMID 17402794
  • Stiehm ER. Adverse effects of human immunoglobulin therapy. Transfus Med Rev. 2013 Jul;27(3):171-8. doi: 10.1016/j.tmrv.2013.05.004. Epub 2013 Jul 6. PMID 23835249

Идентификаторы

NCT: NCT07094048 · MP-20-2025-7948

Первоисточники (государственные реестры)

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