Clinical trial NCT03955900: A Registry Study of Participants With Multiple Myeloma in Latin America
Official title: Latin American Multiple Myeloma Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 2059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Multiple Myeloma (MM)

Brief summary: 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.


Eligibility criteria: 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)

Exclusion Criteria:

* Failed to satisfy one or more of the foregoing inclusion criteria or
* Only with diagnosis of smouldering myeloma between 01 January 2016 and 31 December 2020 in the medical charts

Primary outcomes:
measure: Demographic Characteristics of Multiple Myeloma (MM) Participants
timeFrame: Baseline
measure: Number of Participants with Comorbid Conditions
timeFrame: Baseline
measure: General Health Status Based on Frailty Score
timeFrame: Approximately up to 2.7 years
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Approximately up to 2.7 years
measure: Sequence of Treatments in Participants with Multiple Myeloma (MM)
timeFrame: Approximately up to 2.7 years
measure: Number of Participants in Each Stage of Multiple Myeloma (MM) Disease
timeFrame: Approximately up to 2.7 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately up to 2.7 years
measure: Progression-Free Survival (PFS)
timeFrame: Approximately up to 2.7 years
measure: Percentage of Participants with Complete Response (CR)
timeFrame: Approximately up to 2.7 years
measure: Percentage of Participants with Stringent Complete Response (sCR)
timeFrame: Approximately up to 2.7 years
measure: Duration of Response
timeFrame: Approximately up to 2.7 years
measure: Time to Next Treatment
timeFrame: Approximately up to 2.7 years
measure: Percentage of Participants who Adopted Treatment Regimens
timeFrame: Approximately up to 2.7 years
measure: Number of Participants with Adverse Events
timeFrame: Approximately up to 2.7 years
measure: Number of Participants who Underwent Different Types of Minimal Residual Disease (MRD) Tests
timeFrame: Approximately up to 2.7 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fundaleu
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Oncologia Angel H. Roffo
city: Cordoba
country: Argentina
facility: Hospital Privado - Centro Medico de Cordoba
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Botucatu
country: Brazil
facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: CEHON
city: Sao Paulo
country: Brazil
facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
city: São Paulo
country: Brazil
facility: Clinica Sao Germano
city: São Paulo
country: Brazil
facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center
city: Bogota
country: Colombia
facility: Hospital Universitario Mayor - Mederi
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota
city: Cali
country: Colombia
facility: Clinica de Occidente
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Guadalajara
country: Mexico
facility: Centro de Investigación Farmacéutica Especializada
city: Huixquilucan
country: Mexico
facility: Hospital Angeles Lomas
city: Panama
country: Panama
facility: Centro Hemato Oncologico Paitilla
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: