Real-World Treatment Patterns and Clinical Outcomes in Multiple Myeloma in the Asia-Pacific Region: Methodology and Preliminary Results of the Asia-Pacific Myeloma and Related Diseases Registry (APAC MRDR)
Authors: Aoki Naomi , Moore Elizabeth M. , Wood Erica M. , McQuilten Zoe , Wellard Cameron , Spencer Andrew 
Published: November 2019

Introduction:
Recent studies suggest that incidence of multiple myeloma (MM) is increasing in Asian countries. Prevalence is also expected to rise due to ageing populations and advances in treatment. Therapeutic options continue to expand as new, targeted agents enter the market. However, despite advances in therapy and supportive care, MM remains incurable. Most patients receive care outside the setting of clinical trials. Therefore, the generation of Real-World Evidence (RWE) on practice, including long-term monitoring and evaluation of current and future treatment strategies, is important in informing optimal therapies for MM and enable benchmarking to improve outcomes, quality of life (QoL), and cost-effectiveness of care for patients. Some country-specific data are available in Asia, but few at regional level.
We established the Asia-Pacific (APAC) Myeloma and Related Diseases Registry (MRDR) in 2018, as a regional collaboration and sister registry to the Australian and New Zealand MRDR (ACTRN12618000659202). The aims are collection of a standardised APAC dataset for analysis and benchmarking. Key opinion leaders from the participating countries were invited to form the steering committee to provide local clinical context and oversight of the registry. Early in the process, ethics committees and legal counsel were consulted to assist with challenges presented by the diversity in data privacy and ethical regulations across the APAC region. Participating hospitals are responsible for obtaining local ethics approval, patient recruitment, and data collection. Participants provide written informed consent before data collection.
Methods:
The APAC MRDR prospectively collects observational data on patient characteristics, diagnosis, medical history, treatment (including supportive therapies), and outcomes (overall and progression-free survival, and QoL using the EQ-5D-5L) on newly diagnosed MM (NDMM), plasma cell leukaemia, plasmacytoma, and MGUS patients via a secure, country-specific web-based database. Whilst the core dataset is standardised across countries to ensure comparability, regional differences such as units of measurements and local privacy laws were accommodated in the design of each country's database. Participants are reviewed 4-monthly for a minimum of 2 years. Longer-term outcomes will be collected through linkage with local cancer and death registries. Six-monthly hospital reports, providing de-identified, risk-adjusted outcome data at hospital- and country-level, will be provided to contributing hospitals. Preliminary APAC MRDR data from October 2018 to June 2019 were analysed.
Results:
Eleven hospitals now have Institutional Review Board approval to participate and patient recruitment has commenced at 6 hospitals in Korea and Singapore. Sites in Taiwan, Hong Kong, China, and Malaysia are in progress. To date, 182 patients have been enrolled and data collection on these patients is in progress. At the time of analysis, 85% (96/113) were NDMM. Median age was 66 years (IQR: 59-73) and 54% were male. Median EQ5D VAS Health State score at diagnosis was 70 (IQR: 50-80; self-report: 100=best health imaginable, 0=the worst). Comorbidities were present in 47%. Proportion of patients with main paraprotein type IgG: 64%, IgA: 17%, light chain only Kappa: 13%, light chain only Lambda: 6%. Median number of days from diagnosis to chemotherapy was 9.5 (IQR: 3-15). The top two most frequently used first-line regimens for NDMM patients in Korea and Singapore were: Korea: 1. bortezomib/thalidomide/dexamethasone (VTd: 39%), 2. lenalidomide/dexamethasone (Rd: 27%), and Singapore: 1. VTd: 41%, 2. bortezomib/cyclophosphamide/dexamethasone (VCD): 25%. Overall response rate to first-line chemotherapy (≥PR) was 86% (44/51).
Conclusion:
The APAC MRDR database is expanding and, as data mature and feedback is provided to participating sites, will provide RWE that will contribute to our understanding on current myeloma treatment strategies and patient outcomes in the Asia-Pacific region. Future plans include expansion to additional sites and countries, and linkage with local cancer and death registries. The registry can also serve as a regional resource by providing infrastructure and identifying eligible participants for clinical trials and other research.

Disclosures
Aoki: Janssen Asia-Pacific: Research Funding. Moore:Takeda: Research Funding; Gilead: Research Funding. Wood:Bristol-Myers Squibb: Research Funding; Novartis: Research Funding; Alexion: Research Funding; Roche: Research Funding; Takeda: Research Funding; Gilead: Research Funding; Janssen-Cilag: Research Funding; Amgen: Research Funding; CSL Behring: Research Funding; Sanofi: Research Funding; Celgene: Research Funding; Abbvie: Research Funding. McQuilten:Gilead Sciences: Research Funding; CSL Biotherapies: Research Funding; Celgene: Research Funding; AbbVie: Research Funding; Takeda Pharmaceuticals: Research Funding; Janssen-Cilag: Research Funding. Spencer:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Specialised Therapeutics Australia: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.