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

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: No Intervention

• Registration Number: NCT03506386
• Lead Sponsor: Takeda

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).

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-24
• Study Start: 2018-08-09
• Primary Completion: 2019-11-08
• Study Completion: 2020-01-27
• Status Verified: 2021-01
• Results First Submitted: 2021-01-19
• Results First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Results First Posted: 2021-02-08
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 943

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma Participants	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics	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.
Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns	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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.
Duration of Treatment	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'.

Trial Locations

Locations (17)

Centro de Hematologia e Oncologia (CEHON); 🇧🇷 Salvador, BA, Brazil

Hospital Sao Rafael; 🇧🇷 Salvador, BA, Brazil

Hospital das Clinicas da UFG; 🇧🇷 Goiania, GO, Brazil

Hospital das Clinicas da UFMG; 🇧🇷 Belo Horizonte, MG, Brazil

Clinica de Tratamento e Pesquisa em Hematologia LTDA.; 🇧🇷 Cuiaba, Mount, Brazil

Fundacao IMEPEN; 🇧🇷 Juiz de Fora, MG, Brazil

Hospital das Clinicas da UFPR; 🇧🇷 Curitiba, PR, Brazil

CIONC - Centro Integrado de Oncologia de Curitiba; 🇧🇷 Curitiba, PR, Brazil

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil

Centro de Pesquisas Oncologicas (CEPON); 🇧🇷 Florianopolis, SC, Brazil

Hospital Amaral Carvalho; 🇧🇷 Jau, SP, Brazil

Hospital Sao Vicente de Paulo; 🇧🇷 Passo Fundo, RS, Brazil

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Clinica Sao Germano; 🇧🇷 Sao Paulo, SP, Brazil

Hospital do Servidor Publico de SP; 🇧🇷 Sao Paulo, SP, Brazil

Casa de Saude Santa Marcelina; 🇧🇷 Sao Paulo, SP, Brazil

Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, SP, Brazil