Clinical trial NCT03506386: Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis
Official title: Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Real World Evidence , Multiple Myeloma Profile, Brazil
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-04-24
Enrollment: 943
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each participant should be included in the study only once. For study sites with a system that allows identification of participants with MM electronically, for example using International Classification of Diseases, 10th revision (ICD-10), this will be the preferred method of participant screening for eligibility. For study sites without such capabilities, participant screening will rely on manual selection of institutional charts or other means. In these cases, every effort should be made to identify every possible eligible participant.

Brief summary: The purpose of this study is to present a descriptive analysis of demographic and clinical characteristics of the participants, as well as of the treatment patterns for multiple myeloma (MM) in Brazil.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent, for participants who are alive and not lost to follow-up (for participants already deceased or lost follow up, informed consent should have been waived by the corresponding ethics review board \[ERB\]).
2. Documented diagnosis of MM by the responsible physician between January 1, 2008, and December 31, 2016.
3. Absence of any plasma-cell disorder other than MM.
4. Absence of any immunoglobulin-related disorder other than MM.

Primary outcomes:
measure: Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics
timeFrame: From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]
measure: Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns
timeFrame: From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years]
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of diagnosis up to death within the period of interest (between January 1, 2008, and December 31, 2016) or up to the end of this study [up to 11.7 years]
measure: Duration of Treatment
timeFrame: From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first up to the end of this study (up to 11.7 years)
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Hematologia e Oncologia (CEHON)
state: BA
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
state: BA
city: Goiania
country: Brazil
facility: Hospital das Clinicas da UFG
state: GO
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas da UFMG
state: MG
city: Juiz de Fora
country: Brazil
facility: Fundacao IMEPEN
state: MG
city: Cuiaba
country: Brazil
facility: Clinica de Tratamento e Pesquisa em Hematologia LTDA.
state: Mount
city: Curitiba
country: Brazil
facility: Hospital das Clinicas da UFPR
state: PR
city: Curitiba
country: Brazil
facility: CIONC - Centro Integrado de Oncologia de Curitiba
state: PR
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas (CEPON)
state: SC
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital do Servidor Publico de SP
state: SP
city: Sao Paulo
country: Brazil
facility: Clinica Sao Germano
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
state: SP
city: Sao Paulo
country: Brazil
facility: Casa de Saude Santa Marcelina
state: SP
Study officials:
affiliation: Takeda
name: Medical Monitor Clinical Science
role: STUDY_DIRECTOR
References: