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Completed

NCT Number: NCT03506386

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro de Hematologia e Oncologia (CEHON), Salvador, Estado de Bahia, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]).
  • Documented diagnosis of MM by the responsible physician between January 1, 2008, and December 31, 2016.
  • Absence of any plasma-cell disorder other than MM.
  • Absence of any immunoglobulin-related disorder other than MM.

Treatment and study plan

No intervention

Other

As it was an observational study, no intervention was administered.

Primary outcomes

  1. Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics

    Time frame: 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]

    MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories.

  2. Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns

    Time frame: 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]

    Treatment patterns were collected from institutional charts [included public institution, private institution and both (90% public and 10% private) institutions] of participants in Brazil. The treatment patterns were collected as induction treatment, consolidation treatment, maintenance treatment performed at Baseline (at initial diagnosis) and as a induction treatment, maintenance treatment and type of treatment performed after transplantation, for second to tenth line of treatment. Only categories with data are reported. Participants were counted multiple times in different categories.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 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]

    Overall survival was defined as the time elapsed between the date of diagnosis until death, with censoring of participants who were alive when last seen or who lost to follow up.

  2. Duration of Treatment

    Time frame: 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)

    Duration of treatment was defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who lost to follow-up before discontinuation. Duration of treatment was classified by participants eligibility- eligible/not eligible for transplantation. The deaths occurred after treatment initiation to end of study are reported in categories 'Since Diagnosis to Death-Eligible and Not Eligible'.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis

Acronym: MMyBRave

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2018
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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