Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis (MMyBRave)

Takeda

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03506386

NDMM-5004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 943 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

943 participants in 1 patient group

Multiple Myeloma Participants

Description:

Participants with multiple myeloma (MM) were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study.

Treatment:

Other: No Intervention