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

NCT03506386 | Completed Results

• 1 other identifier: NDMM-5004
• Study Type: observational
• Target: 943
• Locations: 1 country
• Sites: 17

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.

Conditions

Multiple Myeloma

Keywords

Real World Evidence , Multiple Myeloma Profile, Brazil

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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]

• 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)

Study Arms (1)

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

Interventions

No Intervention OTHER

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

Multiple Myeloma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (17)

Centro de Hematologia e Oncologia (CEHON)

Salvador, Estado de Bahia, 40110-150, Brazil

Location

Hospital Sao Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital das Clinicas da UFG

Goiânia, Goiás, 74605-020, Brazil

Location

Hospital das Clinicas da UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Fundacao IMEPEN

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Clinica de Tratamento e Pesquisa em Hematologia LTDA.

Cuiabá, Mount, 78055-000, Brazil

Location

Hospital das Clinicas da UFPR

Curitiba, Paraná, 80060-900, Brazil

Location

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, 80810-050, Brazil

Location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

Location

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Centro de Pesquisas Oncologicas (CEPON)

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

Location

Hospital do Servidor Publico de SP

São Paulo, São Paulo, 04029-000, Brazil

Location

Clinica Sao Germano

São Paulo, São Paulo, 04537-081, Brazil

Location

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Casa de Saude Santa Marcelina

São Paulo, São Paulo, 08270-060, Brazil

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Monitor Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: April 24, 2018
• Study Start: August 9, 2018
• Primary Completion: November 8, 2019
• Study Completion: January 27, 2020
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

BR (17)