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Multiple MyelomaMYLACRENCT03955900

A Registry Study of Participants With Multiple Myeloma in Latin America

An observational study of Multiple Myeloma, run by Janssen-Cilag Ltd. at 22 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
How many people
2,059 participants
Where
22 sitesin 5 countries
Study dates
29 May 2019to 30 Jun 2022
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with Multiple Myeloma (MM)

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

Brazil9 sites

  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

    Botucatu, 18618-686

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

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

    Rio de Janeiro, 22775-001

  • CEHON

    Salvador, 45995-000

  • Clinica Sao Germano

    São Paulo, 01455-010

  • Fundação Antônio Prudente - A.C. Camargo Cancer Center

    São Paulo, 01508-010

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

    São Paulo, 04037-002

  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

    São Paulo, 04039-004

Other trials in Brazil

Argentina5 sites

  • Fundaleu

    Buenos Aires, C1114AAP

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Instituto de Oncologia Angel H. Roffo

    Buenos Aires, C1417DTB

  • Hospital Privado - Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

Other trials in Argentina

Colombia5 sites

  • Hospital Universitario Mayor - Mederi

    Bogotá, 00000

  • Fundacion Santa Fe de Bogota

    Bogotá, 110111

  • Clinica de Occidente

    Cali

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004

  • Hospital Pablo Tobon Uribe

    Medellín, 0000

Other trials in Colombia

Mexico2 sites

  • Centro de Investigación Farmacéutica Especializada

    Guadalajara, 44160

  • Hospital Angeles Lomas

    Huixquilucan, 52787

Other trials in Mexico

Panama1 site

  • Centro Hemato Oncologico Paitilla

    Panama City, 00000

Other trials in Panama

About this study

Official title: Latin American Multiple Myeloma Registry Study

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.

Being tested
No intervention
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

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

Study groups in NCT03955900
Study groupRoleWhat they receive
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.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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).

    Measured: Approximately up to 2.7 years

  4. 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.

    Measured: Approximately up to 2.7 years

  5. Sequence of Treatments in Participants with Multiple Myeloma (MM)

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

    Measured: Approximately up to 2.7 years

  6. 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.

    Measured: Approximately up to 2.7 years

Secondary outcomes (9)

  1. Overall Survival (OS)

    The OS in MM participants will be measured and reported from diagnosis to the date of death.

    Measured: Approximately up to 2.7 years

  2. 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.

    Measured: Approximately up to 2.7 years

  3. 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.

    Measured: Approximately up to 2.7 years

  4. 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.

    Measured: Approximately up to 2.7 years

  5. 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.

    Measured: Approximately up to 2.7 years

  6. Time to Next Treatment

    Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.

    Measured: Approximately up to 2.7 years

  7. Percentage of Participants who Adopted Treatment Regimens

    Percentage of participants who adopted treatment regimens will be reported.

    Measured: Approximately up to 2.7 years

  8. 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.

    Measured: Approximately up to 2.7 years

  9. 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].

    Measured: Approximately up to 2.7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start29 May 2019
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,059 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955900
Sponsor's protocol ID
CR108622
Other IDs
54767414MMY4021
Acronym
MYLACRE
Status last verified
Mar 2023
First submitted
17 May 2019
Last updated
7 Mar 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39657126

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Janssen-Cilag Ltd. at 22 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Brazil, Argentina, Colombia, Mexico, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic Characteristics of Multiple Myeloma (MM) Participants (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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