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出境医 / 临床实验 / A Registry Study of Participants With Multiple Myeloma in Latin America (MYLACRE)

A Registry Study of Participants With Multiple Myeloma in Latin America (MYLACRE)

Study Description
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.

Condition or disease Intervention/treatment
Multiple Myeloma Other: No intervention

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Latin American Multiple Myeloma Registry Study
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
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
Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.

Outcome Measures
Primary Outcome Measures :
  1. Demographic Characteristics of Multiple Myeloma (MM) Participants [ Time Frame: Baseline ]
    Demographic characteristics (such as age, gender, race, ethnicity, country of residence, and health insurance) of MM participants will be assessed at baseline.

  2. Number of Participants with Comorbid Conditions [ Time Frame: Baseline ]
    Number of participants with comorbid conditions (such as obesity, diabetes, cardiovascular disease, anemia alcohol, and tobacco use) will be assessed at baseline.

  3. General Health Status Based on Frailty Score [ Time Frame: Approximately up to 2.7 years ]
    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).

  4. Eastern Cooperative Oncology Group (ECOG) Performance Status Score [ Time Frame: Approximately up to 2.7 years ]
    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.

  5. Sequence of Treatments in Participants with Multiple Myeloma (MM) [ Time Frame: Approximately up to 2.7 years ]
    Treatment sequences for participants with MM within routine clinical care will be assessed.

  6. Number of Participants in Each Stage of Multiple Myeloma (MM) Disease [ Time Frame: Approximately up to 2.7 years ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately up to 2.7 years ]
    The OS in MM participants will be measured and reported from diagnosis to the date of death.

  2. Progression-Free Survival (PFS) [ Time Frame: Approximately up to 2.7 years ]
    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.

  3. Percentage of Participants with Complete Response (CR) [ Time Frame: Approximately up to 2.7 years ]
    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.

  4. Percentage of Participants with Stringent Complete Response (sCR) [ Time Frame: Approximately up to 2.7 years ]
    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.

  5. Duration of Response [ Time Frame: Approximately up to 2.7 years ]
    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.

  6. Time to Next Treatment [ Time Frame: Approximately up to 2.7 years ]
    Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.

  7. Percentage of Participants who Adopted Treatment Regimens [ Time Frame: Approximately up to 2.7 years ]
    Percentage of participants who adopted treatment regimens will be reported.

  8. Number of Participants with Adverse Events [ Time Frame: Approximately up to 2.7 years ]
    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.

  9. Number of Participants who Underwent Different Types of Minimal Residual Disease (MRD) Tests [ Time Frame: Approximately up to 2.7 years ]
    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].


Eligibility Criteria
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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:   Probability Sample
Study Population
Participants with Multiple Myeloma (MM)
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Layout table for investigator information
Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
Tracking Information
First Submitted Date May 17, 2019
First Posted Date May 20, 2019
Last Update Posted Date March 5, 2021
Actual Study Start Date May 29, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
  • Demographic Characteristics of Multiple Myeloma (MM) Participants [ Time Frame: Baseline ]
    Demographic characteristics (such as age, gender, race, ethnicity, country of residence, and health insurance) of MM participants will be assessed at baseline.
  • Number of Participants with Comorbid Conditions [ Time Frame: Baseline ]
    Number of participants with comorbid conditions (such as obesity, diabetes, cardiovascular disease, anemia alcohol, and tobacco use) will be assessed at baseline.
  • General Health Status Based on Frailty Score [ Time Frame: Approximately up to 2.7 years ]
    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).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Sequence of Treatments in Participants with Multiple Myeloma (MM) [ Time Frame: Approximately up to 2.7 years ]
    Treatment sequences for participants with MM within routine clinical care will be assessed.
  • Number of Participants in Each Stage of Multiple Myeloma (MM) Disease [ Time Frame: Approximately up to 2.7 years ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2019)
  • Overall Survival (OS) [ Time Frame: Approximately up to 2.7 years ]
    The OS in MM participants will be measured and reported from diagnosis to the date of death.
  • Progression-Free Survival (PFS) [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Percentage of Participants with Complete Response (CR) [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Percentage of Participants with Stringent Complete Response (sCR) [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Duration of Response [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Time to Next Treatment [ Time Frame: Approximately up to 2.7 years ]
    Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.
  • Percentage of Participants who Adopted Treatment Regimens [ Time Frame: Approximately up to 2.7 years ]
    Percentage of participants who adopted treatment regimens will be reported.
  • Number of Participants with Adverse Events [ Time Frame: Approximately up to 2.7 years ]
    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.
  • Number of Participants who Underwent Different Types of Minimal Residual Disease (MRD) Tests [ Time Frame: Approximately up to 2.7 years ]
    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].
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Registry Study of Participants With Multiple Myeloma in Latin America
Official Title Latin American Multiple Myeloma Registry Study
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with Multiple Myeloma (MM)
Condition Multiple Myeloma
Intervention Other: No intervention
Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
Study Groups/Cohorts 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.
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries Argentina,   Brazil,   Colombia,   Mexico,   Panama
Removed Location Countries  
 
Administrative Information
NCT Number NCT03955900
Other Study ID Numbers CR108622
54767414MMY4021 ( Other Identifier: Janssen-Cilag Ltd. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen-Cilag Ltd.
Study Sponsor Janssen-Cilag Ltd.
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
PRS Account Janssen-Cilag Ltd.
Verification Date March 2021