Study to Evaluate Efficacy and Safety of Belantamab-based Combinations for 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: Belantamab mafodotin, Bortezomib, Dexamethasone, Pomalidomide.
- Кому может быть актуально
- Состояния в реестре: Relapse 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Retrospective Observational Study to Evaluate the Effectiveness and Safety of Belantamab Mafodotin-based Combinations (Belantamab Mafodotin, Bortezomib, Dexamethasone [BVd] or Belantamab Mafodotin, Pomalidomide, Dexamethasone [BPd]) Used as Compassionate Use in Patients With Multiple Myeloma in First or Second Relapse
Обзор
The goal of this retrospective observational study is to characterize multiple myeloma (MM) patients (by collecting demographics, disease characteristics and treatment history data) treated in first or second relapse with belantamab mafodotin combinations under compassionate use conditions.
Подробное описание
This retrospective observational study will collect data from MM patients at first or second relapse to evaluate the response rates under belantamab mafodotin-based therapeutic schedules as salvage therapy.
Data from participants either treated with belantamab mafodotin+bortezomib+dexamethasone \[BVd\] or belantamab mafodotin+pomalidomide+dexamethasone \[BPd\] schedules will be evaluated. Data collection will include the following data:
* Sociodemographics (demographic data, disease status and clinical chracteristics). * Medical history (MM diagnosis, disease characteristics and history of prior treatment with anti-MM therapies). * Treatment with BVd or BPd (overall response rate, duration of response, progression-free survival at diagnosis, progression-free survival at relapse, duration of the treatment, overall survival, side effects, infections and concomitant treatments during the treatment with belantamab-based schedules).
Вмешательства
- Препарат Belantamab mafodotin
All participants evaluated in this study must have received this drug as salvage therapy in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded. - Препарат Bortezomib
Participants in BVd arm must have received this drug in combination with belantamab mafodotin in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded. - Препарат Dexamethasone
All participants evaluated in this study must have received this drug as salvage therapy in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded. - Препарат Pomalidomide
Participants in BPd arm must have received this drug in combination with belantamab mafodotin in first or second relapse. Doses, dose reductions, increased spacing between doses and number of total infusions will be recorded.
Первичные конечные точки
- Patient year of birth [Срок оценки: 18 months]
- Patient sex [Срок оценки: 18 months]
- Patient weight [Срок оценки: 18 months]
- Disease diagnosis date [Срок оценки: 18 months]
- Disease Interational Score System status at diagnosis [Срок оценки: 18 months]
- Disease type of MM (secretory or oligosecretory) [Срок оценки: 18 months]
- Disease type of immunoglobulin [Срок оценки: 18 months]
- Disease ECOG status [Срок оценки: 18 months]
- Disease extramedullar disease at relapse [Срок оценки: 18 months]
- Disease presentation of plasma cell leukemia [Срок оценки: 18 months]
Вторичные конечные точки (9)
- Type of treatment (BVd or BPd) [Срок оценки: 18 months]
- Disease comorbidities [Срок оценки: 18 months]
- Date of drug infusion/administration [Срок оценки: 18 months]
- Drug dose [Срок оценки: 18 months]
- Dose reduction [Срок оценки: 18 months]
- Reason for dose reduction [Срок оценки: 18 months]
- Drug delay [Срок оценки: 18 months]
- New interval between doses [Срок оценки: 18 months]
- Survival data, Overall response rate [Срок оценки: 18 months]
Критерии участия
Критерии включения
- Confirmed diagnosis of relapsed/refractory MM.
- Having received at least one dose of a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions as treatment for a first or second relapse.
- Patients ≥18 years of age at the start of treatment with the belantamab mafodotin combination (BVd or BPd) under compassionate use conditions.
Критерии исключения
- Any patient who has received a belantamab mafodotin combination (BVd or BPd) under compassionate use conditions in fourth line of treatment or later will be excluded from the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07637526 · GEM-BELACOMBOS