Current status of Registry of Monoclonal Gammopathies (RMG) - The First Monitored Real World Database of the Czech Myeloma Group

Introduction:
Collection of “real world“ clinical data in patients with hematologic malignancies by special registries becomes more and more important due to limiting recruitment to clinical trials by entry criteria. Especially low grade malignancies require long term follow-up and valid high quality data. The RMG registry was established in 2007 and has become one of the flagship projects of the Czech Myeloma Group (CMG). To date, five parts of the registry are active - module for monoclonal gammopathies of undetermined significance (MGUS), smoldering mulsiple myeloma (SMM), multiple myeloma (MM), AL amyloidosis (ALA) and Waldenströms macroglobulinemia.
Methods:
All patients must sign a written consent before entering their data into the registry. Data concerning diagnosis, demography, treatment and survival are regularly collected and updated into the registry via online system. The data from patients with monoclonal gammo-pathies are collected predominantly prospectively. Registry is regularly monitored and data are validated by an external monitor similar to clinical trials. The database has been upgraded before 5‚Äâyears, the CLADE-IS system is currently in use. A new system of data visualization was introduced in 2018.
Results:
There are currently 23 participating centers as of June 2022 (19 from the Czech Republic and 4 from Slovakia). Data from 8745 patients with MM, 4610 with MGUS, 303 patients with WM, 77 with ALA and 75 with SMM have been collected. Together 13811 patients have been included in the registry until end of June 2022, 10000th patient was assigned to RMG on October 17th 2018. Median follow-up of MGUS patients is 7‚Äâyears (0.5-46‚Äâyears) and median follow-up for MM patients is 6‚Äâyears (0.5-32‚Äâyears). The huge amount of data allowed already many regular analysis and publication of treatment results of MM patients treated with novel drugs of multiple myeloma in the Czech Republic. The new prognostic models for MGUS and SMM progression have been created based on registry data. The RMG data has been also used in several international projects, such as Insight or Honeur.
Discussion:
The RMG is one of the largest registries in Europe and probably worldwide. Its biggest advantage is collection of validated updated data which can be used to create rapid analyses in order to react to changing myeloma field. It helps us to create new guidelines and serves as a potent research tool. It can be also used to negotiate reimbursement process with healthcare insurance companies and government regulatory authorities for novel drugs implementation into treatment standards.