A Registry Study of Participants With Multiple Myeloma in Latin America

Multiple Myeloma Clinical Trial

— MYLACRE  

Official title:

Latin American Multiple Myeloma Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955900
• Other study ID #: CR108622
• Secondary ID: 54767414MMY4021
• Status: Completed
• Start date: May 29, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2023
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2059
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• No intervention
Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.

Locations

Country	Name	City	State
Argentina	Fundaleu	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Instituto de Oncologia Angel H. Roffo	Buenos Aires
Argentina	Hospital Privado - Centro Medico de Cordoba	Cordoba
Argentina	Hospital Italiano de La Plata	La Plata
Brazil	Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)	Botucatu
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)	Rio de Janeiro
Brazil	CEHON	Salvador
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE	Sao Paulo
Brazil	SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo	Sao Paulo
Brazil	Clinica Sao Germano	São Paulo
Brazil	Fundação Antônio Prudente - A.C. Camargo Cancer Center	São Paulo
Colombia	Fundacion Santa Fe de Bogota	Bogota
Colombia	Hospital Universitario Mayor - Mederi	Bogota
Colombia	Clinica de Occidente	Cali
Colombia	Fundacion Oftalmologica de Santander - FOSCAL	Floridablanca
Colombia	Hospital Pablo Tobon Uribe	Medellin
Mexico	Centro de Investigación Farmacéutica Especializada	Guadalajara
Mexico	Hospital Angeles Lomas	Huixquilucan
Panama	Centro Hemato Oncologico Paitilla	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Overall Survival (OS)	The OS in MM participants will be measured and reported from diagnosis to the date of death.	Approximately up to 2.7 years
Secondary	Progression-Free Survival (PFS)	PFS is defined as time from diagnosis to disease progression. IMWG criteria for disease progression: increase of greater than or equal to (>=)25 percent (%) from lowest response value in any one of the following: Serum M-component (absolute increase must be >=0.5 gram per deciliter [g/dL]), Urine M-component (absolute increase must be >=200 milligram per 24 hour [mg/24 hour]), only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be greater than >10 mg/dL), Bone marrow plasma cell percentage: the absolute percent must be >=10%, Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder.	Approximately up to 2.7 years
Secondary	Percentage of Participants with Complete Response (CR)	Complete response (CR) per International Myeloma Working Group (IMWG 2014) criteria is defined by negative immunofixation on the serum and urine, disappearance of any soft-tissue plasmacytomas, and less than (<)5 percent (%) plasma cells in bone marrow.	Approximately up to 2.7 years
Secondary	Percentage of Participants with Stringent Complete Response (sCR)	Stringent CR per IMWG criteria is defined by a below plus normal fee-light-chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.	Approximately up to 2.7 years
Secondary	Duration of Response	Duration of response is defined as the time from the date of initial documentation of a response (CR or partial response [PR]) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. Relapse as per IMWG criteria is defined as presence of definite new bone lesions and/or soft-tissue plasmacytomas, with a clear increase in the size of existing plasmacytomas, or hypocalcemia that cannot be attributed to another cause.	Approximately up to 2.7 years
Secondary	Time to Next Treatment	Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.	Approximately up to 2.7 years
Secondary	Percentage of Participants who Adopted Treatment Regimens	Percentage of participants who adopted treatment regimens will be reported.	Approximately up to 2.7 years
Secondary	Number of Participants with Adverse Events	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Approximately up to 2.7 years
Secondary	Number of Participants who Underwent Different Types of Minimal Residual Disease (MRD) Tests	Number of participants who underwent different types of MRD tests will be reported. MRD tests include next-generation [NG] flow cytometry, NG sequencing, positron emission tomography with computed tomography [PET-CT].	Approximately up to 2.7 years