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Идёт набор NCT06855121

The Norwegian Immunotherapy in Multiple Myeloma Study

— Наблюдательное Myeloma Multiple Plasma Cell Leukemia AL Amyloidosis

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: Teclistamab, Elranatamab, Ciltacabtagene Autoleucel, Talquetamab.
Кому может быть актуально
Состояния в реестре: Myeloma Multiple, Plasma Cell Leukemia, AL Amyloidosis. 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
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

Обзор

The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.

Вмешательства

  • Препарат Teclistamab
    Real-world use and dosing
  • Препарат Elranatamab
    Real-world use and dosing
  • Биопрепарат Ciltacabtagene Autoleucel
    Real-world use.
  • Препарат Talquetamab
    Real-world use and dosing
  • Биопрепарат Idecabtagene vicleucel
    Real-world use and dosing

Первичные конечные точки

  • Determine the real-world overall response rates (ORR) [Срок оценки: From date of treatment start and until date of first documented progression or start of next line of therapy, whichever came first, assessed up to ten years.]
  • Determine real-world progression-free survival (PFS) [Срок оценки: From date of treatment start and until date of first documented progression or death, whichever came first, , assessed up to ten years.]
  • Determine real-world time-to-next treatment (TTNT) [Срок оценки: From date of treatment start and until date of start of next treatment, assessed up to ten years.]
  • Determine real-world overall survival (OS) [Срок оценки: From date of treatment start and until death, assessed up to ten years.]
  • Describe the frequency and grading of adverse events of special interest (AESI), defined as described below. [Срок оценки: From date of treatment start until the date of start of next line of treatment or death, whichever came first, assessed up to 10 years]
  • Frequency and grading of all other adverse events occurring during treatment according to CTCAE 5.0 (only grade 3 or higher will be reported). [Срок оценки: From start of treatment and until start of next treatment or death, assessed up to ten years.]
  • Describe the microbiological pattern (positive cultures/PCR) of infections during treatment. [Срок оценки: From start of treatment and start of next treatment line or death, assessed up to ten years.]
  • Describe the antibiotic resistance pattern of positive cultures. [Срок оценки: From start of treatment and start of next treatment line or death, assessed up to ten years.]
  • Describe the prevalence of common airway viruses during treatment and at end-of-treatment. [Срок оценки: From date of start of treatment and until end of treatment, assessed up to ten years.]
  • Determine the real-world use of antimicrobial prophylaxis (antibiotics, antivirals, vaccines, immunoglobulines) before and during therapy. [Срок оценки: From enrollment and until end of treatment, assessed up to ten years.]

Критерии участия

Критерии включения

  • Participants age ≥ 18 years
  • Prior diagnosis of one of the following
  • Multiple myeloma as defined according to IMWG criteria
  • Primary plasma cell leukemia as defined according to IMWG consensus definition
  • AL-amyloidosis as defined according to IMWG criteria
  • Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU):
  • Teclistamab (Tecvayli)
  • Elranatamab (Elrexfio)
  • Talquetamab (Talvey)
  • Idecabtagene vicleucel (ide-cel/Abecma)
  • Ciltacabtagene autoleucel (cilta-cel/Carvykti)

Критерии исключения

  • None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Норвегия · 23 центра
  • Sørlandet Hospital - Arendal — Arendal
  • Ålesund hospital, Department of hematology — Ålesund
  • Haukeland University Hospital — Bergen
  • Bodø Hospital — Bodø
  • Bærum Hospital — Bærum
  • Drammen hospital — Drammen
  • Førde hospital — Førde
  • Innlandet hospital trust — Gjøvik
  • … и ещё 15 центров

Идентификаторы

NCT: NCT06855121 · NIMMS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗