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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 multiple myeloma (MM) in Brazil.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Myeloma Participants | Participants with multiple myeloma (MM) were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | As it was an observational study, no intervention was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics | MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories. | From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years] |
| Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns | Treatment patterns were collected from institutional charts [included public institution, private institution and both (90% public and 10% private) institutions] of participants in Brazil. The treatment patterns were collected as induction treatment, consolidation treatment, maintenance treatment performed at Baseline (at initial diagnosis) and as a induction treatment, maintenance treatment and type of treatment performed after transplantation, for second to tenth line of treatment. Only categories with data are reported. Participants were counted multiple times in different categories. | From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years] |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time elapsed between the date of diagnosis until death, with censoring of participants who were alive when last seen or who lost to follow up. | From the date of diagnosis up to death within the period of interest (between January 1, 2008, and December 31, 2016) or up to the end of this study [up to 11.7 years] |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Hematologia e Oncologia (CEHON) | Salvador | Estado de Bahia | 40110-150 | Brazil | ||
| Hospital Sao Rafael |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Multiple Myeloma (MM) were observed to collect data retrospectively between eligibility window: 1 January 2008 to 31 December 2016, in this study.
Participants took part in the study at 17 investigative sites in Brazil from 9 August 2018 to 27 January 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Myeloma Participants | Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants eligible for analyses were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiple Myeloma Participants | Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Multiple Myeloma (MM) Participants Categorized by Clinical Characteristics | MM clinical characteristics upon diagnosis were classified by eligibility criteria for transplantation (eligible/not eligible) and included: presence of plasma cells in the bone marrow by biopsy and aspiration, bone or extramedullary biopsy, plasma cells determined by immunohistochemistry (Yes/No/Unknown), plasma cells determined by flow cytometry (Yes/No/Unknown) hypercalcemia, renal failure, anemia, and bone lesions features (more than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size), presence of monoclonal proteins (immunoglobulin (Ig)G, IgG kappa, IgG lambda, IgA, IgA kappa, IgA lambda, kappa only, lambda only, IgD, IgE, IgM, Non-secretory and Unknown), free light chain ratio (serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L). Only categories with data are reported. Participants were counted multiple times in different categories. | All participants eligible for analyses were included. Number analyzed are the participants with data available for analyses of the specific category. | Posted | Count of Participants | Participants | From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years] |
From diagnosis up to the end of this study (up to 11.7 years)
Only deaths were collected, and data of adverse events or adverse drug reactions were not collected as part of the study database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multiple Myeloma Participants | Participants with MM were observed retrospectively since the diagnosis up to death or lost to follow-up within the eligibility window of time (between January 1, 2008 and December 31, 2016), in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | Jan 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Duration of Treatment | Duration of treatment was defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who lost to follow-up before discontinuation. Duration of treatment was classified by participants eligibility- eligible/not eligible for transplantation. The deaths occurred after treatment initiation to end of study are reported in categories 'Since Diagnosis to Death-Eligible and Not Eligible'. | From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first up to the end of this study (up to 11.7 years) |
| Salvador |
| Estado de Bahia |
| 41253-190 |
| Brazil |
| Hospital das Clinicas da UFG | Goiânia | Goiás | 74605-020 | Brazil |
| Hospital das Clinicas da UFMG | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Fundacao IMEPEN | Juiz de Fora | Minas Gerais | 36036-330 | Brazil |
| Clinica de Tratamento e Pesquisa em Hematologia LTDA. | Cuiabá | Mount | 78055-000 | Brazil |
| Hospital das Clinicas da UFPR | Curitiba | Paraná | 80060-900 | Brazil |
| CIONC - Centro Integrado de Oncologia de Curitiba | Curitiba | Paraná | 80810-050 | Brazil |
| Universidade Federal do Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
| Hospital Sao Vicente de Paulo | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Centro de Pesquisas Oncologicas (CEPON) | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil |
| Hospital do Servidor Publico de SP | São Paulo | São Paulo | 04029-000 | Brazil |
| Clinica Sao Germano | São Paulo | São Paulo | 04537-081 | Brazil |
| Hospital das Clinicas da FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Casa de Saude Santa Marcelina | São Paulo | São Paulo | 08270-060 | Brazil |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Multiple Myeloma (MM) Participants Categorized by Treatment Patterns | Treatment patterns were collected from institutional charts [included public institution, private institution and both (90% public and 10% private) institutions] of participants in Brazil. The treatment patterns were collected as induction treatment, consolidation treatment, maintenance treatment performed at Baseline (at initial diagnosis) and as a induction treatment, maintenance treatment and type of treatment performed after transplantation, for second to tenth line of treatment. Only categories with data are reported. Participants were counted multiple times in different categories. | All participants eligible for analyses were included. Number analyzed are the number of participants with evaluable data for given category. | Posted | Count of Participants | Participants | From initial diagnosis up to end of follow up treatment or to the retrospective cut-off date within the time of interest (between January 1, 2008, and December 31, 2016) [approximately 11.7 years] |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival was defined as the time elapsed between the date of diagnosis until death, with censoring of participants who were alive when last seen or who lost to follow up. | All participants eligible for analyses who had non-missing observations were analyzed. Number analyzed is the number of participants with data available for given category. | Posted | Median | Full Range | days | From the date of diagnosis up to death within the period of interest (between January 1, 2008, and December 31, 2016) or up to the end of this study [up to 11.7 years] |
|
|
|
|
| Secondary | Duration of Treatment | Duration of treatment was defined with respect to selected lines or regimens of interest, considering the time elapsed from each treatment initiation to discontinuation, and censoring participants who lost to follow-up before discontinuation. Duration of treatment was classified by participants eligibility- eligible/not eligible for transplantation. The deaths occurred after treatment initiation to end of study are reported in categories 'Since Diagnosis to Death-Eligible and Not Eligible'. | All participants eligible for analyses who had non-missing observations were analyzed. Number analyzed is the number of participants with data available for given category. | Posted | Median | Full Range | years | From treatment initiation up to discontinuation of treatment or lost to follow-up, whichever occurs first up to the end of this study (up to 11.7 years) |
|
|
|
| 436 |
| 943 |
| 0 |
| 0 |
| 0 |
| 0 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Both (90% public and 10% private) Institutions |
|
| Baseline: Consolidation Treatment Performed |
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| Baseline: Maintenance Treatment Performed |
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| 2nd Line: Induction Treatment Performed |
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| 2nd Line: Maintenance Treatment Performed |
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| 2nd Line: Type of Treatment Performed After Transplantation |
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| 3rd Line: Induction Treatment Performed |
|
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| 3rd Line: Maintenance Treatment Performed |
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| 3rd Line: Type of Treatment Performed After Transplantation |
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| 4th Line: Induction Treatment Performed |
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| 4th Line: Maintenance Treatment Performed |
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| 4th Line: Type of Treatment Performed After Transplantation |
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| 5th Line: Induction Treatment Performed |
|
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| 5th line: Maintenance Treatment Performed |
|
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| 5th Line: Type of Treatment Performed After Transplantation |
|
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| 6th Line: Induction Treatment Performed |
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| 6th Line: Maintenance Treatment Performed |
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| 7th Line: Induction Treatment Performed |
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| 8th Line: Induction Treatment Performed |
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| 9th Line: Induction Treatment Performed |
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| 10th Line: Induction Treatment Performed |
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| Not Eligible for Transplantation |
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| Since Diagnosis to Lost to Follow-up: Eligible |
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| Since Diagnosis to Lost to Follow-up: Not Eligible |
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| Since Diagnosis to Death: Eligible |
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| Since Diagnosis to Death: Not Eligible |
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