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Multiple Myeloma (MM) Profile in Brazil: A Retrospective Observational Analysis (MMyBRave)

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ClinicalTrials.gov Identifier: NCT03506386
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to present a descriptive analysis of demographic and clinical characteristics of the participants, as well as of the treatment patterns for MM in Brazil.

Condition or disease
Multiple Myeloma

Detailed Description:

Participants with a diagnosis of MM will be observed in this retrospective study. Data collected for the study will include identification, demographic, baseline data on MM, additional baseline laboratory, initial treatment for MM, subsequent treatment for MM, and outcome.

The study will enroll approximately 1000 participants.

This multi-center trial will be conducted in five geographic regions of Brazil. For each participant, data collection will comprise the longest possible period of time since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation (initiation defined as the initiation visit for the first site).


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multiple Myeloma Profile in Brazil: A Retrospective Observational Analysis
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
MM participants
Participants diagnosed with MM and have initiated treatment will be observed since the diagnosis of MM (within the eligibility window of time, between January 1, 2008 and December 31, 2016) and the cut-off date for data collection (December 31, 2016), unless a participant has died or been lost to follow-up before that. The study is planned to last for approximately 24 months since its initiation. Initiation defined as the initiation visit for the first site.



Primary Outcome Measures :
  1. Number of MM Participants Categorized by Clinical Characteristics [ Time Frame: From initial diagnosis (within the eligibility window of time, between January 1, 2008, and December 31, 2016) up to end of follow up treatment or to the cut-off date for data collection (December 31, 2016) (approximately 8 years) ]
    MM clinical characteristics upon diagnosis included: percentage of plasma cells in the bone marrow, hypercalcemia, renal failure, anemia, and bone lesions (CRAB) features, presence of monoclonal protein, free light chain ratio, and focal lesion on magnetic resonance imaging (MRI).

  2. Treatment Patterns [ Time Frame: From initial diagnosis (within the eligibility window of time, between January 1, 2008, and December 31, 2016) up to end of follow up treatment or to the cut-off date for data collection (December 31, 2016) (approximately 8 years) ]
    Treatment patterns will be collected from January 01, 2008 to December 31, 2016 from institutional charts of participants in Brazil.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From the date of diagnosis up to death (approximately 8 years) ]
    Overall survival will be defined as the time elapsed between the date of diagnosis until death, with censoring of participants who are alive when last seen or who are lost to follow up.

  2. Duration of Treatment [ Time Frame: From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first (approximately 8 years) ]
    Duration of treatment will be defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who are lost to follow-up before discontinuation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Each participant should be included in the study only once. For study sites with a system that allows identification of participants with MM electronically, for example using International Classification of Diseases, 10th revision (ICD-10), this will be the preferred method of participant screening for eligibility. For study sites without such capabilities, participant screening will rely on manual selection of institutional charts or other means. In these cases, every effort should be made to identify every possible eligible participant.
Criteria

Inclusion Criteria:

  1. Provision of written informed consent, for participants who are alive and not lost to follow-up (for participants already deceased or lost follow up, informed consent should have been waived by the corresponding ethics review board [ERB]).
  2. Documented diagnosis of MM by the responsible physician between January 1, 2008, and December 31, 2016.
  3. Absence of any plasma-cell disorder other than MM.
  4. Absence of any immunoglobulin-related disorder other than MM.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506386


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Brazil
Centro de Hematologia e Oncologia (CEHON) Recruiting
Salvador, BA, Brazil, 40110-150
Hospital Sao Rafael Recruiting
Salvador, BA, Brazil, 41253-190
Hospital Sirio Libanes Recruiting
Brasilia, DF, Brazil, 70200-730
Acreditar Oncologia S.A Not yet recruiting
Brasilia, DF, Brazil, 70297-400
Hospital Universitario da UnB Not yet recruiting
Brasilia, DF, Brazil, 70840-901
Hospital das Clinicas da UFG Recruiting
Goiania, GO, Brazil, 74605-020
Hospital das Clinicas da UFMG Recruiting
Belo Horizonte, MG, Brazil, 30130-100
Fundacao IMEPEN Recruiting
Juiz de Fora, MG, Brazil, 36036-330
Clinica de Tratamento e Pesquisa em Hematologia LTDA. Recruiting
Cuiaba, Mount, Brazil, 78055-000
Hospital das Clinicas da UFPR Not yet recruiting
Curitiba, PR, Brazil, 80060-900
CIONC - Centro Integrado de Oncologia de Curitiba Recruiting
Curitiba, PR, Brazil, 80810-050
Universidade Federal do Rio de Janeiro Not yet recruiting
Rio de Janeiro, RJ, Brazil, 21941-590
Hospital Sao Vicente de Paulo Recruiting
Passo Fundo, RS, Brazil, 99010-080
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-903
Centro de Pesquisas Oncologicas (CEPON) Recruiting
Florianopolis, SC, Brazil, 88034-000
Hospital Amaral Carvalho Recruiting
Jau, SP, Brazil, 17210-080
Hospital do Servidor Publico de SP Recruiting
Sao Paulo, SP, Brazil, 04029-000
Clinica Sao Germano Recruiting
Sao Paulo, SP, Brazil, 04537-081
Hospital das Clinicas da FMUSP Recruiting
Sao Paulo, SP, Brazil, 05403-000
Casa de Saude Santa Marcelina Recruiting
Sao Paulo, SP, Brazil, 08270-060
Sponsors and Collaborators
Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03506386     History of Changes
Other Study ID Numbers: NDMM-5004
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Real World Evidence , Multiple Myeloma Profile, Brazil

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases