Condition or disease | Intervention/treatment |
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Multiple Myeloma | Other: No intervention |
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 |
Group/Cohort | Intervention/treatment |
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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.
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Other: No intervention
Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Study Contact | 844-434-4210 | JNJ.CT@sylogent.com |
Study Director: | Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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 |
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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.
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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. ) |
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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 |
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PRS Account | Janssen-Cilag Ltd. | ||||
Verification Date | March 2021 |