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| ID | Type | Description | Link |
|---|---|---|---|
| PCI-32765MMY4001 | Other Identifier | Janssen-Cilag Ltd. |
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The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.
This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Chronic Lymphocytic Leukemia (CLL) | This is an observational study. Data will be captured for Participant's with diagnosis of Chronic Lymphocytic Leukemia according to hospital records in the questionnaire provided by the Sponsor. |
| |
| Participants with Multiple Myeloma (MM) | This is an observational study. Data will be captured for Participant's with diagnosis of Multiple Myeloma (MM) according to hospital records in the questionnaire provided by the Sponsor. |
| |
| Participants with Non-Hodgkin's lymphoma (NHL) | This is an observational study. Data will be captured for Participant's with diagnosis of non-Hodgkin's lymphoma (NHL) data according to hospital records in the questionnaire provided by the Sponsor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) | Other | This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Previous Comorbidities | Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other. | 1 year |
| Number of Participants as per treatment therapy received | Cancer treatment (Chronic Lymphocytic Leukemia [CLL], Multiple Myeloma [MM] and non-Hodgkin lymphoma [NHL]) for all participants is summarized by the number of participants who had any type of surgery or radiotherapy (external radiation or brachytherapy) or other drug treatments. | 1 year |
| Overall survival | Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause. | 1 year |
| Number of Participants with Response to Treatment | Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL) | Incidence of CLL, MM and NHL will be reported. It is a percentage of the population at risk of developing the disease. | 1 year |
| Prevalence Percentage of Participants with CLL, MM and NHL |
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Inclusion Criteria:
Exclusion Criteria:
- Having one and only one consult in the center
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Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33095117 | Derived | Chiattone C, Gomez-Almaguer D, Pavlovsky C, Tuna-Aguilar EJ, Basquiera AL, Palmer L, de Farias DLC, da Silva Araujo SS, Galvez-Cardenas KM, Gomez Diaz A, Lin JH, Chen YW, Machnicki G, Mahler M, Parisi L, Barreyro P. Real-world analysis of treatment patterns and clinical outcomes in patients with newly diagnosed chronic lymphocytic leukemia from seven Latin American countries. Hematology. 2020 Dec;25(1):366-371. doi: 10.1080/16078454.2020.1833504. |
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| Multiple Myeloma (MM) | Other | This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year. |
|
| Non-Hodgkin's lymphoma (NHL) | Other | This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year. |
|
Prevalence of CLL, MM and NHL will be reported. Prevalence will be estimated using available population demographic information as the denominators and using the percentage of registered participants with those cancers at the sites as the numerators. |
| 1 year |
| Córdoba |
| Argentina |
| La Plata Lpl Lpl | Argentina |
| Belo Horizonte | Brazil |
| Fortaleza | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| São José do Rio Preto | Brazil |
| São Paulo | Brazil |
| Santiago | Chile |
| Bogotá | Colombia |
| Bogotá Dc | Colombia |
| Cali | Colombia |
| Floridablanca | Colombia |
| Medellín | Colombia |
| Guatemala City | Guatemala |
| Huixquilucan | Mexico |
| Mexico City | Mexico |
| México | Mexico |
| Monterrey | Mexico |
| Toluca | Mexico |
| Panama City | Panama |
| Panama Republic Panama | Panama |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
| D008206 | Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C078247 | non-Hodgkin's lymphoma protocol 8503 |
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