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

Multiple Myeloma 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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: No Intervention

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).

• Study Type: Observational
• Enrollment (Actual): 943

Contacts and Locations

Study Locations

• Brazil
  • BA
    • Salvador, BA, Brazil, 40110-150
      • Centro de Hematologia e Oncologia (CEHON)
    • Salvador, BA, Brazil, 41253-190
      • Hospital Sao Rafael
  • GO
    • Goiania, GO, Brazil, 74605-020
      • Hospital das Clínicas da UFG
  • MG
    • Belo Horizonte, MG, Brazil, 30130-100
      • Hospital das Clinicas da Ufmg
    • Juiz de Fora, MG, Brazil, 36036-330
      • Fundação IMEPEN
  • Mount
    • Cuiaba, Mount, Brazil, 78055-000
      • Clinica de Tratamento e Pesquisa em Hematologia LTDA.
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Hospital das Clínicas da UFPR
    • Curitiba, PR, Brazil, 80810-050
      • CIONC - Centro Integrado de Oncologia de Curitiba
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-590
      • Universidade Federal do Rio de Janeiro
  • RS
    • Passo Fundo, RS, Brazil, 99010-080
      • Hospital Sao Vicente de Paulo
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
  • SC
    • Florianopolis, SC, Brazil, 88034-000
      • Centro de Pesquisas Oncologicas (CEPON)
  • SP
    • Jau, SP, Brazil, 17210-080
      • Hospital Amaral Carvalho
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas da FMUSP
    • Sao Paulo, SP, Brazil, 04029-000
      • Hospital do Servidor Publico de SP
    • Sao Paulo, SP, Brazil, 04537-081
      • Clinica Sao Germano
    • Sao Paulo, SP, Brazil, 08270-060
      • Casa de Saude Santa Marcelina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple Myeloma Participants; 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.	Other: No Intervention; As it was an observational study, no intervention was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics	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.	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]
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	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]
Duration of Treatment	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'.	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)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2018
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): January 27, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Real World Evidence , Multiple Myeloma Profile, Brazil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: NDMM-5004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No