A Registry Study of Participants With Multiple Myeloma in Latin America

NCT03955900 | Completed

• 2 other identifiers: CR10862254767414MMY4021
• Study Type: observational
• Target: 2,059
• Locations: 5 countries
• Sites: 22

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

• Demographic Characteristics of Multiple Myeloma (MM) Participants

  Demographic characteristics (such as age, gender, race, ethnicity, country of residence, and health insurance) of MM participants will be assessed at baseline.

  Baseline

• Number of Participants with Comorbid Conditions

  Number of participants with comorbid conditions (such as obesity, diabetes, cardiovascular disease, anemia alcohol, and tobacco use) will be assessed at baseline.

  Baseline

• General Health Status Based on Frailty Score

  General health status based on Frailty Score will be reported. International Myeloma Working Group (IMWG) frailty score: Participants frailty status will be assessed on the basis of 4 components: age (less than \[\<75\], 76- 80, and greater than \[\>\]80 years correspond to frailty scores of 0, 1, and 2, respectively), the charlson comorbidity scoring system without age weighting (scores of less than or equal to \[\<=\]1 and greater than or equal to \[\>=\]2 correspond to frailty scores of 0 and 1, respectively), independence in activities of daily living (scores of \>4 and \<=4 correspond to frailty scores of 0 and 1, respectively) and instrumental activities of daily living scale (scores of \>5 and \<=5 correspond to frailty scores of 0 and 1, respectively). The sum of the 4 frailty scores equals the total frailty score. The total frailty score ranges from 0 to 5, with a total of three categories: 0 (fit), 1 (intermediate-fitness) and greater than or equal to (\>=)2 (frail).

  Approximately up to 2.7 years

• Eastern Cooperative Oncology Group (ECOG) Performance Status Score

  ECOG performance status is a standard criterion for measuring how the disease impacts daily living abilities. It describes the level of functioning in terms of the ability to care for oneself, daily activity, and physical ability (walking, working, etc). ECOG performance status score ranges from Grade 0 to 5: 0= Fully active and performances without restriction, 1= Restricted in physically strenuous activity, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, 3= Capable of only limited self-care and confined to bed or chair more than 50% of waking hours, 4= Completely disabled, and 5= Dead.

  Approximately up to 2.7 years

• Sequence of Treatments in Participants with Multiple Myeloma (MM)

  Treatment sequences for participants with MM within routine clinical care will be assessed.

  Approximately up to 2.7 years

• Number of Participants in Each Stage of Multiple Myeloma (MM) Disease

  Number of participants in each stage of MM disease will reported. The stage of MM disease will be determined by International Staging System (ISS). ISS categorizes MM participants into three groups (Stage I, II, or III). Stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/L) and albumin greater than or equal to (\>=)3.5 gram (g)/100 milliliter (mL); stage II: neither stage I nor stage III; and stage III: beta2-microglobulin \>=5.5 mg/L.

  Approximately up to 2.7 years

Secondary Outcomes (9)

• Overall Survival (OS)

  Approximately up to 2.7 years

• Progression-Free Survival (PFS)

  Approximately up to 2.7 years

• Percentage of Participants with Complete Response (CR)

  Approximately up to 2.7 years

• Percentage of Participants with Stringent Complete Response (sCR)

  Approximately up to 2.7 years

• Duration of Response

  Approximately up to 2.7 years

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

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

Participants with Multiple Myeloma (MM)

Eligibility Criteria

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

Study Population

Participants with Multiple Myeloma (MM)

You may qualify if:

• 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)

You may not qualify if:

• Only with diagnosis of smouldering myeloma between 01 January 2016 and 31 December 2020 in the medical charts

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (22)

Fundaleu

Buenos Aires, C1114AAP, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Instituto de Oncologia Angel H. Roffo

Buenos Aires, C1417DTB, Argentina

Location

Hospital Privado - Centro Medico de Cordoba

Córdoba, X5016KEH, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1900AXI, Argentina

Location

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, 18618-686, Brazil

Location

Liga Norte Riograndense Contra O Cancer

Natal, 59062-000, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

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

Rio de Janeiro, 22775-001, Brazil

Location

CEHON

Salvador, 45995-000, Brazil

Location

Clinica Sao Germano

São Paulo, 01455-010, Brazil

Location

Fundação Antônio Prudente - A.C. Camargo Cancer Center

São Paulo, 01508-010, Brazil

Location

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

São Paulo, 04037-002, Brazil

Location

Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

São Paulo, 04039-004, Brazil

Location

Hospital Universitario Mayor - Mederi

Bogotá, 00000, Colombia

Location

Fundacion Santa Fe de Bogota

Bogotá, 110111, Colombia

Location

Clinica de Occidente

Cali, Colombia

Location

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, 681004, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, 0000, Colombia

Location

Centro de Investigación Farmacéutica Especializada

Guadalajara, 44160, Mexico

Location

Hospital Angeles Lomas

Huixquilucan, 52787, Mexico

Location

Centro Hemato Oncologico Paitilla

Panama City, 00000, Panama

Location

Related Publications (1)

• 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.

  PMID: 39657126 DERIVED

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

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 20, 2019
• Study Start: May 29, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CO (5); AR (5); BR (9); ME (2); PA (1)