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1604 Brazilian Real-World Multiple Myeloma (MM) Electronic Platform Register Project

Program: Oral and Poster Abstracts
Session: 902. Health Services Research—Malignant Conditions (Lymphoid Disease): Poster I
Hematology Disease Topics & Pathways:
multiple myeloma, Adult, Diseases, Plasma Cell Disorders, Lymphoid Malignancies, Study Population, Clinically relevant
Saturday, December 5, 2020, 7:00 AM-3:30 PM

Edvan De Queiroz Crusoe, MD, PhD1,2, Glaciano Ribeiro, MD3*, Karla Richter Zanella, MD4*, Leila Martins Perobelli, MD5*, Milton A. F. Aranha, MD6*, Marcelo Capra, MD, PhD7, Roberto José Pessoa Magalhães, MD8*, James Maciel9*, Rosane Bittencourt, MD10*, Emanuella Souza11*, Rafael Dezen Gaiolla, PhD, MD12*, Walter Braga, MD13*, Fabiana Higashi, MD14*, Gracia Martinez, MD, PhD15*, Abrahão Elias Hallack Neto, MD, PhD16*, Danielle Leao Cordeiro De Farias, MD, MSc, MBA17, Virgilio Costa Farnese, MD18*, Nelson S Castro, MD19*, Renato Tavares, MD20*, Jacqueline Holanda De Souza, MD21*, Jandey Glória Bigonha, MD22*, Ederson Roberto Mattos, MD23*, Caroline Sola, MD24*, Joao Tadeu Souto Filho, MD, PhD25, LUiza da Silva, MD26*, Cleder Aparecido Da Silva Da Silva Araujo, MD27*, Jorge Vaz Pinto Neto, MD28*, Emanuel Silva, MD29*, Nelson Hamerschlak, MD, PhD30, Fabio Moore Nucci, MD, PhD31*, Eduardo Flavio Oliveira Ribeiro, MD32, Rafael Cunha, MD33*, Andre H Crepaldi, MD34*, Manuella Sampaio Almeida, MD35*, Gislaine B O Duarte, MD36*, Andre Magalhaes, MD37*, Dani Laks, MD, PhD38*, Marcos Daniel, MD39*, Angelo Maiolino, MD40 and Vania T. M. Hungria, MD, PhD41

1Rua Dra Doutro Vianna S/n, Universidade Federal da Bahia- Hospital Universitario, Salvador, Brazil
2Hematology department- D'or Oncologia, Clinica CEHON Rede D'or Oncologia, Salvador, Brazil
3Clínica Hematologica, Belo Horizonte - Minas Gerais, Brazil
4Clinica Viver- CEPHON, Florianópolis, BRA
5Hospital de Transplantes Euryclides de Jesus Zerbini, São Paulo, Brazil
6Instituto Hemomed de Oncologia e Hematologia, São Paulo, BRA
7Hospital do Cancer Mae de Deus, Porto Alegre, PB, Brazil
8Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil
9Liga Norte-Riograndense Contra o Câncer, Natal, BRA
10Hematology Division, University Hospital of the Federal University of Rio Grande do Sul, Porto Alegre, Brazil
11Federal University of Minas Gerais, Belo Horizonte, BRA
12Hospital Das Clínicas UNESP, Distrito De Rubiao Junior, Botucatu, BRA
13Univsersidade Federal de Sao Paulo- UNIFESP, São Paulo, Brazil
15University of Sao Paulo, Sao Paulo, Brazil
16Division of Hematology and Oncology, Universidade Federal de Juiz de Fora, São Pedro, Brazil
17Hospital Beneficência Portuguesa de São Paulo, São Paulo, Brazil
18Federal University of Uberlandia, Sao Paulo, BRA
19Hospital de Câncer de Barretos, Barretos, Brazil
20Hospital das Clinicas, Universidade Federal de Goiania, Goiás, Brazil
22Faculdade de Medicina do ABC, Sao Paulo, BRA
23Fundação Hospital Amaral Carvalho, Jau, BRA
24HC - UFPR, Curitiba, BRA
25Faculdade de Medicina de Campos, Campos dos Goytacazes, Brazil
26Federal University of Alagoas, Maceio, Brazil
27Servidor do servido do estado de minas gerais- IPSEMG, minas gerais, Brazil
28CETTRO, Centro de Cancer de Brasília, Brasília, Brazil
29Hospital Geral de Fortaleza, fortaleza, Brazil
30Hematology, Hospital Israelita Albert Einstein, São Paulo, Brazil
31Hospital Universitário Antônio Pedro, RIO DE JANEIRO, Brazil
32Hospital Santa Lúcia Centro, Brasila, BRA
33Oncoclínica - Centro de Trat. Oncológico Ipanema, Oncoclínica - Centro de Trat. Oncolínico Barra, Centro de Excelência Oncológica - CEON, Rio De Janeiro, BRA
34NUTEC, Cuiaba, BRA
35Hospital Santa Marcelina, sao paulo, Brazil
36Hematology and Hemotherapy Center, University of Campinas, Campinas, Brazil
37Clinica CEHON- Juazeiro, Juazeiro-BA, Brazil
38Instituto de Hematologia- Porto Alegre, Porto Alegre-RS, Brazil
39Universidade Federal do Espírito Santo, Vila Velha, BRA
40Hospital Universitario Clementino Fraga Filho Universidade Federal do Rio de Jan, Rio de Janeiro, Brazil
41Department of Hematology, Clinica São Germano and Santa Casa Medical School, São Paulo, Brazil

Introduction: An epidemiological database is an important tool to characterize the population disease distribution, long-term effects of the diseases, impact of evolving treatments, to identify adverse events (AE) and their possible mitigation and to improve the healthcare system. Another important reason to create a database is to rapidly identify, recruit and enroll individuals for research activities. Based on these, the Brazilian Multiple Myeloma Study Group (GBRAM) developed an electronic database platform with the intention of prospectively registering the MM cases diagnosed at Brazilian healthcare services. Methods: This is a prospective, multicenter, open, epidemiological study, based on an electronic system register. Patients diagnosed with MM after January 1, 2018 have been included. The eligibility criteria were: intent-to-treat (ITT) MM patients, aged over 18 years and under care in any healthcare system (private, public and academic). All clinical and laboratory data, prognostic profiling, treatment patterns and responses, AE and survival were compiled. The data were analyzed with the NCSS® 2020 software. This project is registered in the Brazilian study platform control (Plataforma Brasil) linked to federal health authorities by the number CAAE-05340918.3.1001.8098. Results: To date, 1,113 patients at 44 reference centers were included. The median age was 64 (25 -96) years and 578 (52%) were male. According to the ECOG performance status: 0 = 185 (16.5%), 1 = 257 (23.2%), 2 = 144 (13%), 3 = 105 (9.5%), 4 = 62 (5.5%) and the not available data (NA) = 359 (32.3%). The ISS 1, 2, and 3 were 219 (19.7%), 286 (25.7%) and 406 (36.5%), respectively, the NA being 202 (18.1%). MM isotypes were 524 (47.1%) IgG, 202 (18.2%) IgA, 192 (17.2%) free-light chain, 4 (0.5%) IgM, 7 (0.8%) biclonal, 9 (0.7%) non-secretor and 175 (15.5%) NA. Regarding the treatment backbone, 427 (38.4%) patients received immunomodulators (IMID- thalidomide), 277 (20.4%), proteasome inhibitors (PI-bortezomib), 84 (7.6%), the combination of PI + IMID, 72 (6.6%), combinations with anti-CD38 monoclonal antibody (Daratumumab) and 253 (27%), other treatments. Based on the ITT analysis of 1003 cases, 636 (63.4%) patients were planned for bone marrow transplantation (BMT) and 367 (36.6%) were ineligible. After a median follow-up of 14.0 months, 150 (23.6%) of the planned patients had undergone the procedure, 284 (44.7%) had not yet been submitted and 202 (31.7%) had NA data. The overall survival (OS) was 80.9% for the total group at 20 months, 73.5% for ineligible and 95.5% for eligible. There was a significant improvement in eligible patients who had performed BMT, as compared to those who had not, HR 0.15 (0.09 - 0.26), p < 0.0001. A total of 142 deaths (12.8%) occurred, 51 (36%) of them being during the first 180 days. Discussion: Due to the lack of a reliable national register and the undoubtable need for a better understanding of MM for the development of public health and patient support measures, GBRAM has developed and built an electronic platform. This epidemiological study prospectively enrolled patients diagnosed since January 2018 and is of a nationwide scope. To date, 1,113 new cases were included. Despite the short follow-up, this analysis has identified differences in survival, comparing ISS stratifications and whether a BMT was performed or not. Conclusion: This project demonstrates the feasibility and importance of electronic platforms in the compilation of MM populational data for a better understanding of the clinical characteristics, treatment patterns and outcomes in the real world, permitting a clearer perception of local issues and thus, addressing possible improvement in public healthcare policy, such as the improvement of BMT access.

Disclosures: De Queiroz Crusoe: Janssen: Research Funding. Aranha: Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Ache Pharmaceutics: Honoraria.

*signifies non-member of ASH