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

Completed

• Conditions: Leukemia; Non-Hodgkin; Multiple Myeloma; Lymphoid; Lymphoma
• Interventions: Other: Multiple Myeloma (MM); Other: Non-Hodgkin's lymphoma (NHL); Other: Chronic Lymphocytic Leukemia (CLL)

• Registration Number: NCT02559583
• Lead Sponsor: Janssen-Cilag Ltd.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5443

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Multiple Myeloma (MM)	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)	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.
Participants with Chronic Lymphocytic Leukemia (CLL)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Previous Comorbidities	1 year	Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.
Number of Participants as per treatment therapy received	1 year	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.
Overall survival	1 year	Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.
Number of Participants with Response to Treatment	1 year	Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.

Secondary Outcome Measures

Name	Time	Method
Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)	1 year	Incidence of CLL, MM and NHL will be reported. It is a percentage of the population at risk of developing the disease.
Prevalence Percentage of Participants with CLL, MM and NHL	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.