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

Multiple Myeloma Clinical Trial

— MMyBRave  

Official title:

Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03506386
• Other study ID #: NDMM-5004
• Status: Completed
• Start date: August 9, 2018
• Est. completion date: January 27, 2020

Study information

• Verified date: January 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 943
• Est. completion date: January 27, 2020
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• No Intervention
As it was an observational study, no intervention was administered.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da UFMG	Belo Horizonte	MG
Brazil	Clinica de Tratamento e Pesquisa em Hematologia LTDA.	Cuiaba	Mount
Brazil	CIONC - Centro Integrado de Oncologia de Curitiba	Curitiba	PR
Brazil	Hospital das Clinicas da UFPR	Curitiba	PR
Brazil	Centro de Pesquisas Oncologicas (CEPON)	Florianopolis	SC
Brazil	Hospital das Clinicas da UFG	Goiania	GO
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Fundacao IMEPEN	Juiz de Fora	MG
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo	RS
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro	RJ
Brazil	Centro de Hematologia e Oncologia (CEHON)	Salvador	BA
Brazil	Hospital Sao Rafael	Salvador	BA
Brazil	Casa de Saude Santa Marcelina	Sao Paulo	SP
Brazil	Clinica Sao Germano	Sao Paulo	SP
Brazil	Hospital das Clinicas da FMUSP	Sao Paulo	SP
Brazil	Hospital do Servidor Publico de SP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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	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]
Secondary	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)