Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America

NCT ID: NCT02559583

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5443 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Multiple Myeloma; Leukemia; Lymphoid; Lymphoma; Non-Hodgkin

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Chronic Lymphocytic Leukemia (CLL)

Intervention Type: OTHER

This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.

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.

Multiple Myeloma (MM)

Intervention Type: OTHER

This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.

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.

Non-Hodgkin's lymphoma (NHL)

Intervention Type: OTHER

This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.

Interventions

Chronic Lymphocytic Leukemia (CLL)

This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.

Intervention Type: OTHER

Multiple Myeloma (MM)

This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.

Intervention Type: OTHER

Non-Hodgkin's lymphoma (NHL)

This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Locations

Buenos Aires, , Argentina

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

Countries

Argentina; Brazil; Chile; Colombia; Guatemala; Mexico; Panama

References

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.

Reference Type: DERIVED

PMID: 33095117 (View on PubMed)

Other Identifiers

PCI-32765MMY4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR105066

Identifier Type: -

Identifier Source: org_study_id