Clinical trial NCT02559583: Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America
Official title: Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Leukemia
Lymphoid
Lymphoma
Non-Hodgkin
Keywords: Multiple Myeloma
chronic lymphocytic leukemia
Non-Hodgkin lymphoma
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 5443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
* At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
* Participant must sign a participation agreement/informed consent form (ICF)

Exclusion Criteria:

- Having one and only one consult in the center

Primary outcomes:
measure: Number of Participants with Previous Comorbidities
timeFrame: 1 year
measure: Number of Participants as per treatment therapy received
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Number of Participants with Response to Treatment
timeFrame: 1 year
Secondary outcomes:
measure: Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)
timeFrame: 1 year
measure: Prevalence Percentage of Participants with CLL, MM and NHL
timeFrame: 1 year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma De Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: La Plata Lpl Lpl
country: Argentina
city: Belo Horizonte
country: Brazil
city: Fortaleza
country: Brazil
city: Goiânia
country: Brazil
city: Porto Alegre
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
city: Santiago
country: Chile
city: Bogota N/A
country: Colombia
city: Bogota
country: Colombia
city: Bogotá Dc
country: Colombia
city: Cali
country: Colombia
city: Floridablanca
country: Colombia
city: Medellín
country: Colombia
city: Guatemala City
country: Guatemala
city: Ciudad De Mexico
country: Mexico
city: Huixquilucan
country: Mexico
city: Mexico City
country: Mexico
city: Mexico Df
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: Toluca
country: Mexico
city: Panama Republic Panama
country: Panama
city: Panama
country: Panama
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.