| Condition or disease | Intervention/treatment |
|---|---|
| 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 |
|---|---|
|
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.
|
| 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 |
Show 22 study locations
| 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 |
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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 |
||||
| 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
|
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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 | ||||