Clinical Research Platform for Molecular Testing, Treatment and Outcome of Patients With Multiple Myeloma (Myeloma Registry Platform; MYRIAM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Course of treatment (treatment reality)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No systemic therapy for myeloma
- •Patients already enrolled in studies that prohibit any participation in other studies
结局指标
主要结局
Course of treatment (treatment reality)
时间窗: 5 years per patient
Documentation of anamnestic data and therapy sequences
次要结局
- Health-related quality of life (Patient-reported outcome)(5 years per patient)
- Best Response(5 years per patient)
- Progression-free survival(5 years per patient)
- Myeloma-specific health-related quality of life (Patient-reported outcome)(5 years per patient)
- Quality of life (Patient-reported outcome)(5 years per patient)
- Overall survival(5 years per patient)