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

Multiple Myeloma Clinical Trial

— HOLA  

Official title:

Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559583
• Other study ID #: CR105066
• Secondary ID: PCI-32765MMY4001
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2015
• Last updated: July 19, 2016
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Comisión Federal para la Prevención contra Riesgos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5443
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin

Intervention

Other:
• Chronic Lymphocytic Leukemia (CLL)
This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.
• Multiple Myeloma (MM)
This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.
• Non-Hodgkin's lymphoma (NHL)
This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Guatemala,  Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Previous Comorbidities	Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.	1 year	No
Primary	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	No
Primary	Overall survival	Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.	1 year	No
Primary	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	No
Secondary	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	No
Secondary	Prevalence Percentage of Participants with CLL, MM and NHL	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	No