Registry of Monoclonal Gammopathies (RMG) in the Czech Republic

Abstract

Introduction: Collection of valid data in patients with hematologic malignancies remains a challenge. 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. To date, four parts of the registry are active - module for multiple myeloma (MM), monoclonal gammopathies of undetermined significance (MGUS), AL amyloidosis (ALA) and Waldeströms macroglobulinemia. The later two has been started in 2014. Aim: To analyze current status of the registry in terms of amount of contained data. 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 at https://trials.cba.muni.cz/trialdb2/interface_forms/login_rmg.asp. The data from MGUS patients are retrospective and prospective, data from MM patients are only prospective (since 2007). Registry is regularly monitored and data are validated by an external monitor. Results: There are 22 participating centers as of July 2015 (18 from the Czech Republic and 4 from Slovakia). Data from 4549 patients with MM, 2168 with MGUS, 121 patients with WM and 22 with ALA have been collected. Together 6860 patients have been included in the registry as of July 2015. Median follow-up of MGUS patients is 4 years (0-35 years) and median follow-up for MM patients is 2 years (0-32 years). The huge amount of data allowed publication of treatment results of MM patients treated with bortezomid and thalidomide in the Czech Republic and regular analysis of patients treated with lenalidomide. Novel prognostic models for MGUS progression and asymptomatic myeloma have been created based on registry data (manuscripts submitted). Conclusion: The RMG is one of the largest registries in Europe. 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 with healthcare insurance companies and government regulatory authorities for novel drugs implementation into treatment standards. Supported by The Ministry of Education, Youth and Sports (Specific university research of the Faculty of Medicine, University of Ostrava) project no. SGS01/LF/2014-2015, by the Moravian-Silesian Region - grant no. MSK 02692/2014/RRC, by the Institutional Development Plan of University of Ostrava in 2015, financial resources are allocated by The Ministry of Education, Youth and Sports. Supported by grant NT14575. Disclosures Hajek: Amgen: Honoraria; Celgene: Consultancy; Janssen: Consultancy.

Development and validation of a novel risk stratification algorithm for relapsed multiple myeloma

“…In addition, the RMG has mature OS data and is representative of the national and international patient populations. For these reasons, the RMG was selected for development of the RSA (Radocha et al , ). Data were collected from all 20 of the Czech centres that actively treat patients with MM; these centres cover approximately 80% of all patients with MM in the Czech Republic (Radocha et al , ).…”

“…For these reasons, the RMG was selected for development of the RSA (Radocha et al , ). Data were collected from all 20 of the Czech centres that actively treat patients with MM; these centres cover approximately 80% of all patients with MM in the Czech Republic (Radocha et al , ). Data collection began in May 2007, and patients were observed from diagnosis until either death, loss to follow‐up or 26 April 2016.…”

Methodology of a Novel Risk Stratification Algorithm for Patients with Multiple Myeloma in the Relapsed Setting

“…The Czech Registry of Monoclonal Gammopathies (RMG) is one of the largest of its kind and contains data on a substantial number of patients with MM initiating 2L treatment [15], as well as mature OS data and information on a large number of parameters [15]. This RSA was developed using validated and quality-controlled data that were collected between May 2007 and April 2016.…”

“…This RSA was developed using validated and quality-controlled data that were collected between May 2007 and April 2016. Informed consent was granted in the original study of the RMG [15]. The data in this study are based on a previously conducted study, and informed consent was granted in the original study.…”

Methodology and results of real-world cost-effectiveness of carfilzomib in combination with lenalidomide and dexamethasone in relapsed multiple myeloma using registry data

“…Observational databases, however, capture characteristics and outcomes of patients receiving treatment in real life: the Registry of Monoclonal Gammopathies (RMG), for instance, captures a wide range of data of MM patients in the Czech Republic, and comparisons across published studies demonstrate that differences exist between RCTs and the RW, e.g. outcomes of patients treated with lenalidomide and dexamethasone (Rd) are considerably lower in RW patients compared with those in recent RCTs [11][12][13][14][15][16]. Additionally, the limited time duration of RCTs pose an extra hurdle for the generalisation of economic model results in the RW, as the time horizon of economic models often requires extrapolation of clinical data well beyond the trial duration; [17] in registries and observational databases patients may be followed for longer periods and consequently the uncertainty around long-term estimates may be considerably lower than that obtained as a result of extrapolation of trial data [9,17,18].…”