Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis (MMyBRave)
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|ClinicalTrials.gov Identifier: NCT03506386|
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : May 29, 2019
|Condition or disease|
Participants with a diagnosis of MM will be observed in this retrospective study. Data collected for the study will include identification, demographic, baseline data on MM, additional baseline laboratory, initial treatment for MM, subsequent treatment for MM, and outcome.
The study will enroll approximately 1000 participants.
This multi-center trial will be conducted in five geographic regions of Brazil. For each participant, data collection will comprise the longest possible period of time since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation (initiation defined as the initiation visit for the first site).
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis|
|Actual Study Start Date :||August 9, 2018|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
Participants diagnosed with MM and have initiated treatment will be observed since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation. Initiation defined as the initiation visit for the first site.
- Number of MM Participants Categorized by Clinical Characteristics [ Time Frame: From initial diagnosis (within the eligibility window of time, between January 1, 2008, and December 31, 2016) up to end of follow up treatment or to the cut-off date for data collection (December 31, 2016) (approximately 8 years) ]MM clinical characteristics upon diagnosis included: percentage of plasma cells in the bone marrow, hypercalcemia, renal failure, anemia, and bone lesions (CRAB) features, presence of monoclonal protein, free light chain ratio, and focal lesion on magnetic resonance imaging (MRI).
- Treatment Patterns [ Time Frame: From initial diagnosis (within the eligibility window of time, between January 1, 2008, and December 31, 2016) up to end of follow up treatment or to the cut-off date for data collection (December 31, 2016) (approximately 8 years) ]Treatment patterns will be collected from January 01, 2008 to December 31, 2016 from institutional charts of participants in Brazil.
- Overall Survival [ Time Frame: From the date of diagnosis up to death (approximately 8 years) ]Overall survival will be defined as the time elapsed between the date of diagnosis until death, with censoring of participants who are alive when last seen or who are lost to follow up.
- Duration of Treatment [ Time Frame: From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first (approximately 8 years) ]Duration of treatment will be defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who are lost to follow-up before discontinuation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506386
|Contact: Takeda Study Registration Call Centeremail@example.com|
|Centro de Hematologia e Oncologia (CEHON)||Recruiting|
|Salvador, BA, Brazil, 40110-150|
|Hospital Sao Rafael||Recruiting|
|Salvador, BA, Brazil, 41253-190|
|Hospital Sirio Libanes||Recruiting|
|Brasilia, DF, Brazil, 70200-730|
|Acreditar Oncologia S.A||Not yet recruiting|
|Brasilia, DF, Brazil, 70297-400|
|Hospital Universitario da UnB||Not yet recruiting|
|Brasilia, DF, Brazil, 70840-901|
|Hospital das Clinicas da UFG||Recruiting|
|Goiania, GO, Brazil, 74605-020|
|Hospital das Clinicas da UFMG||Recruiting|
|Belo Horizonte, MG, Brazil, 30130-100|
|Juiz de Fora, MG, Brazil, 36036-330|
|Clinica de Tratamento e Pesquisa em Hematologia LTDA.||Recruiting|
|Cuiaba, Mount, Brazil, 78055-000|
|Hospital das Clinicas da UFPR||Not yet recruiting|
|Curitiba, PR, Brazil, 80060-900|
|CIONC - Centro Integrado de Oncologia de Curitiba||Recruiting|
|Curitiba, PR, Brazil, 80810-050|
|Universidade Federal do Rio de Janeiro||Not yet recruiting|
|Rio de Janeiro, RJ, Brazil, 21941-590|
|Hospital Sao Vicente de Paulo||Recruiting|
|Passo Fundo, RS, Brazil, 99010-080|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035-903|
|Centro de Pesquisas Oncologicas (CEPON)||Recruiting|
|Florianopolis, SC, Brazil, 88034-000|
|Hospital Amaral Carvalho||Recruiting|
|Jau, SP, Brazil, 17210-080|
|Hospital do Servidor Publico de SP||Recruiting|
|Sao Paulo, SP, Brazil, 04029-000|
|Clinica Sao Germano||Recruiting|
|Sao Paulo, SP, Brazil, 04537-081|
|Hospital das Clinicas da FMUSP||Recruiting|
|Sao Paulo, SP, Brazil, 05403-000|
|Casa de Saude Santa Marcelina||Recruiting|
|Sao Paulo, SP, Brazil, 08270-060|