Myeloma Registry Platform (MYRIAM)

Официальное название

Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)

Обзор

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Multiple Myeloma in Germany.

Подробное описание

MYRIAM is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of multiple myeloma in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-realted quality of life in patients with multiple myeloma (MyLife) will be evaluated for up to five years.

Вмешательства

• Другое Routine care as per site standard.
  Physician's choice according to patient's needs.

Первичные конечные точки

• Course of treatment (treatment reality) [Срок оценки: 5 years per patient]

Вторичные конечные точки (6)

• Best Response [Срок оценки: 5 years per patient]
• Progression-free survival [Срок оценки: 5 years per patient]
• Overall survival [Срок оценки: 5 years per patient]
• Health-related quality of life (Patient-reported outcome) [Срок оценки: 5 years per patient]
• Myeloma-specific health-related quality of life (Patient-reported outcome) [Срок оценки: 5 years per patient]
• Quality of life (Patient-reported outcome) [Срок оценки: 5 years per patient]

Критерии участия

Критерии включения

• MM requiring systemic (first-, second- or third-line) treatment (closed for first-line / second-line recruitment)
• Age ≥ 18 years
• Written informed consent

• Patients participating in the PRO satellite: signing of informed consent and completion of baseline questionnaire before, but not more than eight weeks before the start of respective systemic treatment
• Patients not participating in the PRO satellite: signing of informed consent not later than four weeks after start of respective treatment, and not more than eight weeks before the start of respective systemic treatment
• Sufficient German language skills for participation in the PRO satellite

Критерии исключения

• No systemic therapy for myeloma
• Patients already enrolled in studies that prohibit any participation in other studies

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Multiple sites all over germany — Multiple Sites

Публикации

• Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24. PMID 33218965

Идентификаторы

NCT: NCT03308474 · iOM-060331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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