Contributions
Abstract: PB2162
Type: Publication Only
Background
In Germany, multiple myeloma (MM) represents the third most common hematologic malignancy and is still considered incurable with standard treatment regimens. Therapeutic options have markedly increased over the last decade and a number of new treatments that showed promising results in clinical trials may be approved in the near future. However, few so called “real world” data is available regarding the implementation of these new treatments into routine care and their impact on the prognosis of patients with MM treated outside of clinical trials.
Aims
The purpose of MYRIAM is to create a prospective, intersectoral, national, longitudinal, multicenter cohort study to document patient and disease characteristics, treatments, course of disease, including clinical and patient-reported outcomes and consent to perform translational research.
Methods
Between 2017 and 2021 about 2.000 patients with MM giving informed consent at the start of their first or second systemic treatment will be prospectively recruited in 150 different sites, including university hospitals, community hospitals and outpatient clinics (office-based practices) and will be followed until death or for a maximum of 5 years. Data will be collected in electronic case report forms with implemented completeness and plausibility checks, regularly examined by data managers and randomly monitored. Patient-reported outcomes will be assessed at the time of recruitment, every 3 months for the first 24 months and every 6 months thereafter, for a maximum of 5 years altogether using the EORTC-QLQ-C30+MY20 and the Brief Pain Inventory. Patients will be asked to give informed consent for future translational research of their unused tumor samples. Annual interim analysis will be performed. The study was approved by local ethics committees and is registered under clinicaltrials.gov (identifier: NCT03308474).
Results
The first patient was recruited in September 2017. At the time of abstract submission (February 2018), 138 patients had been recruited in 43 sites, and a further 63 sites had already agreed to participate. Data cut for the first planned interim analysis will be April 30th 2018. First results on patient and disease characteristics and initial treatments will be presented.
Conclusion
MYRIAM will for the first time present prospective, intersectoral, longitudinal data on patient characteristics, treatment and outcome of MM patients across all health care sectors in Germany. Data will shed light to the current state of care outside of clinical trails, allow identification of unmet medical needs that can be used to create recommendations to improve care, and will facilitate generation of hypothesis for clinical trials to improve current best practice.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical data, epidemiology, Multiple Myeloma, Quality of Life
Abstract: PB2162
Type: Publication Only
Background
In Germany, multiple myeloma (MM) represents the third most common hematologic malignancy and is still considered incurable with standard treatment regimens. Therapeutic options have markedly increased over the last decade and a number of new treatments that showed promising results in clinical trials may be approved in the near future. However, few so called “real world” data is available regarding the implementation of these new treatments into routine care and their impact on the prognosis of patients with MM treated outside of clinical trials.
Aims
The purpose of MYRIAM is to create a prospective, intersectoral, national, longitudinal, multicenter cohort study to document patient and disease characteristics, treatments, course of disease, including clinical and patient-reported outcomes and consent to perform translational research.
Methods
Between 2017 and 2021 about 2.000 patients with MM giving informed consent at the start of their first or second systemic treatment will be prospectively recruited in 150 different sites, including university hospitals, community hospitals and outpatient clinics (office-based practices) and will be followed until death or for a maximum of 5 years. Data will be collected in electronic case report forms with implemented completeness and plausibility checks, regularly examined by data managers and randomly monitored. Patient-reported outcomes will be assessed at the time of recruitment, every 3 months for the first 24 months and every 6 months thereafter, for a maximum of 5 years altogether using the EORTC-QLQ-C30+MY20 and the Brief Pain Inventory. Patients will be asked to give informed consent for future translational research of their unused tumor samples. Annual interim analysis will be performed. The study was approved by local ethics committees and is registered under clinicaltrials.gov (identifier: NCT03308474).
Results
The first patient was recruited in September 2017. At the time of abstract submission (February 2018), 138 patients had been recruited in 43 sites, and a further 63 sites had already agreed to participate. Data cut for the first planned interim analysis will be April 30th 2018. First results on patient and disease characteristics and initial treatments will be presented.
Conclusion
MYRIAM will for the first time present prospective, intersectoral, longitudinal data on patient characteristics, treatment and outcome of MM patients across all health care sectors in Germany. Data will shed light to the current state of care outside of clinical trails, allow identification of unmet medical needs that can be used to create recommendations to improve care, and will facilitate generation of hypothesis for clinical trials to improve current best practice.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): Clinical data, epidemiology, Multiple Myeloma, Quality of Life