A Registry Study of Participants With Multiple Myeloma in Latin America

NCT ID: NCT03955900

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2059 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-29

Study Completion Date

2022-06-30

Brief Summary

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The purpose of this study is to characterize the multiple myeloma (MM) population concerning demographics and clinical characteristics (for example. frailty, risk strata, manifestations of target organ damage \[TOD\]) in 6 countries (that is Argentina, Brazil, Mexico, Chile, Colombia and Panama); and to profile the treatment landscape of Latin American MM participants, including factors associated with health-care provider (HCP) selections of different treatment regimens. These factors can include a participant's demographic and clinical characteristics and availability of different therapy options per institution in each country.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Multiple Myeloma (MM)

Participants with MM will be observed in real-world clinical practice settings. The primary data source for this study will be the medical records of each participant.

No intervention

Intervention Type OTHER

Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.

Interventions

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No intervention

Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Incident diagnosis of MM between 01 January 2016 and 31 December 2020 (that is the first observed diagnosis noted in the medical charts)
* An informed-consent form (ICF) or participation agreement must be signed before any data are collected only if a waiver is not permissible. For deceased participants who did not provide consent before death, the permission to research on their information should satisfy the local requirements (that each study site's ethics committee and each country's regulatory authority)

* Only with diagnosis of smouldering myeloma between 01 January 2016 and 31 December 2020 in the medical charts
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

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Fundaleu

Buenos Aires, , Argentina

Site Status

Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status

Instituto de Oncologia Angel H. Roffo

Buenos Aires, , Argentina

Site Status

Hospital Privado - Centro Medico de Cordoba

Córdoba, , Argentina

Site Status

Hospital Italiano de La Plata

La Plata, , Argentina

Site Status

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

Site Status

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

Site Status

Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

Site Status

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, , Brazil

Site Status

CEHON

Salvador, , Brazil

Site Status

Clinica Sao Germano

São Paulo, , Brazil

Site Status

Fundação Antônio Prudente - A.C. Camargo Cancer Center

São Paulo, , Brazil

Site Status

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

São Paulo, , Brazil

Site Status

Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

São Paulo, , Brazil

Site Status

Hospital Universitario Mayor - Mederi

Bogotá, , Colombia

Site Status

Fundacion Santa Fe de Bogota

Bogotá, , Colombia

Site Status

Clinica de Occidente

Cali, , Colombia

Site Status

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, , Colombia

Site Status

Hospital Pablo Tobon Uribe

Medellín, , Colombia

Site Status

Centro de Investigación Farmacéutica Especializada

Guadalajara, , Mexico

Site Status

Hospital Angeles Lomas

Huixquilucan, , Mexico

Site Status

Centro Hemato Oncologico Paitilla

Panama City, , Panama

Site Status

Countries

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Argentina Brazil Colombia Mexico Panama

References

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Hungria V, Gaiolla R, Galvez K, Remaggi G, Schutz N, Bittencourt R, Maiolino A, Quintero-Vega G, Cugliari MS, Braga WMT, Villarim CC, Crusoe E, Enrico AI, Caiero G, Bigonha J, Moura FL, Figueroa J, Sossa Melo CL, Lombana M, Pei H, Fernandez M, Saes J, Trufelli DC. Health care systems as determinants of outcomes in multiple myeloma: final results from the Latin American MYLACRE study. Blood Adv. 2025 Mar 25;9(6):1293-1302. doi: 10.1182/bloodadvances.2024013838.

Reference Type DERIVED
PMID: 39657126 (View on PubMed)

Other Identifiers

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54767414MMY4021

Identifier Type: OTHER

Identifier Source: secondary_id

CR108622

Identifier Type: -

Identifier Source: org_study_id

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