RMG – Registry of Monoclonal Gammopathies

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RMG – Registry of Monoclonal Gammopathies

International clinical registry of patients with monoclonal gammopathies.

start of the project: December 2006

The primary goal of the project is to create a parametric database and an information system for the collection and basic analysis of data on diagnosis and therapy of patients affected with monoclonal gammopathy, as well as for the analysis of records on skeletal related events in a routine clinical practice. One prerequisite is the cooperation of major centres in the Central and Eastern Europe, so that a sufficient amount of assessed parameters is gathered. The cooperation with other EU countries is very welcome. The data structure of the system contains all basic items which meet the standards for parametric monitoring of patients diagnosed with monoclonal gammopathy, particularly the records on:

  • diagnosis of the disease, including main risk and prognostic factors
  • monitoring of the therapy process, including the description of results and possible complications

The system is based on the collection of a minimal set of parameters, and is primarily oriented on the epidemiological data, as well as on basic data on survival and results of different therapy approaches in monoclonal gammopathies. The universal and generally applicable data structure of the registry enables a detailed monitoring of any patient. In the first stage, the registry will be used as a basis to record monoclonal gammopathies and to monitor the costly pharmacotherapy in multiple myeloma. Subsequently, this database can be used in other projects, focused on a broader assessment of epidemiology, diagnosis and therapy.

The RMG has been established on two basic principles: (1) each centre has a permanent access to its own data and to basic automatic analyses of these data, (2) collective analyses are based on data from centres which have agreed to share its data for the given project. In this case, the involved centres are mentioned as co-authors of outputs from these analyses.

The project has been designed as a study which had both prospective and retrospective parts. At the time of project initiation (December 2006), both retrospective data (on patients diagnosed in the period 2000–2006) and prospective data (on patients diagnosed since then) were collected. At the present time, only prospective records are collected.

The RMG project is fully open for the cooperation to all cancer centres and cancer groups in the Czech Republic, Slovakia and other European countries. The system is based on an on-line technology, enabling a high-quality central management and administration of data of individual centres; at the same time, the centres' rights as unique owners of clinical data are fully respected. The flexibility and openness of the applied on-line system of data collection and assessment allows a further expansion of the RMG database, customizing it to the requirements of individual centres.

The RMG registry has been designed as a purely epidemiological and explorative study. The project aims to monitor patients with monoclonal gammopathies and their reactions to standard treatment methods. No specific drugs nor treatment procedures are required for patients with monoclonal gammopathies to be involved in the project. Patients involved in the study will be treated with all available treatment modalities, in compliance with the common clinical practice.

  • Expert guarantor: Prof. Roman Hájek, MD, PhD; Prof. Vladimír Maisnar, MD, PhD (Czech Myeloma Group)
  • Partners: haematology centres from the Czech Republic and Slovakia (you can find more detailed information on the website of the RMG project)
  • Brief overview of results: you can find more detailed information on the website of the RMG project
RMG: international clinical registry of patients with monoclonal gammopathies