A Registry Study of Participants With Multiple Myeloma in Latin America

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03955900
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag Ltd. Clinical Trial
Principal Investigator Affiliation Janssen-Cilag Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Brazil, Colombia, Mexico, Panama
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

: 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.

Interventions

Other: - No intervention

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fundaleu, Buenos Aires, Argentina

Status

Active, not recruiting

Address

Fundaleu

Buenos Aires, , C1114AAP

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Status

Active, not recruiting

Address

Hospital Italiano de Buenos Aires

Buenos Aires, , C1181ACH

Instituto de Oncologia Angel H. Roffo, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto de Oncologia Angel H. Roffo

Buenos Aires, , C1417DTB

Cordoba, Argentina

Status

Active, not recruiting

Address

Hospital Privado - Centro Medico de Cordoba

Cordoba, , X5016KEH

Hospital Italiano de La Plata, La Plata, Argentina

Status

Active, not recruiting

Address

Hospital Italiano de La Plata

La Plata, , B1900AXI

Botucatu, Brazil

Status

Recruiting

Address

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, , 18618-686

Liga Norte Riograndense Contra O Cancer, Natal, Brazil

Status

Recruiting

Address

Liga Norte Riograndense Contra O Cancer

Natal, , 59075-740

Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil

Status

Recruiting

Address

Hospital de Clínicas de Porto Alegre

Porto Alegre, , 90035-903

Hospital São Lucas da PUCRS, Porto Alegre, Brazil

Status

Withdrawn

Address

Hospital São Lucas da PUCRS

Porto Alegre, , 90610-000

Rio de Janeiro, Brazil

Status

Recruiting

Address

Instituto COI de Pesquisa, Educacao e Gestao

Rio de Janeiro, , 22793-080

CEHON, Salvador, Brazil

Status

Recruiting

Address

CEHON

Salvador, , 45995-000

Universidade Federal de Sao Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Universidade Federal de Sao Paulo

Sao Paulo, , 04037-002

Sao Paulo, Brazil

Status

Not yet recruiting

Address

Hospital do Servidor Publico Estadual - IAMSPE

Sao Paulo, ,

Clinica Sao Germano, São Paulo, Brazil

Status

Recruiting

Address

Clinica Sao Germano

São Paulo, , 01455-010

São Paulo, Brazil

Status

Not yet recruiting

Address

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, , 05403-000

Hospital Israelita Albert Einstein, São Paulo, Brazil

Status

Withdrawn

Address

Hospital Israelita Albert Einstein

São Paulo, , 05652-900

Fundacion Cardio Infantil Ic, Bogota, Colombia

Status

Withdrawn

Address

Fundacion Cardio Infantil Ic

Bogota, , 0000

Fundacion Santa Fe de Bogota, Bogota, Colombia

Status

Recruiting

Address

Fundacion Santa Fe de Bogota

Bogota, ,

Guadalajara, Mexico

Status

Recruiting

Address

Centro de Investigación Farmacéutica Especializada

Guadalajara, , 44160

Hospital Angeles Lomas, Huixquilucan, Mexico

Status

Recruiting

Address

Hospital Angeles Lomas

Huixquilucan, , 52787

Centro Hemato Oncologico Paitilla, Panama, Panama

Status

Recruiting

Address

Centro Hemato Oncologico Paitilla

Panama, , 00000

Panama, Panama

Status

Withdrawn

Address

Complejo Hospitalario Metropolitano Dr Arnulfo Arias Madrid

Panama, , 00000