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Clinical Trials/NCT02559583
NCT02559583
Completed
Not Applicable

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

Janssen-Cilag Ltd.0 sites5,443 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Myeloma
Sponsor
Janssen-Cilag Ltd.
Enrollment
5443
Primary Endpoint
Number of Participants with Previous Comorbidities
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
June 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Participants with Previous Comorbidities

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 1 year

Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.

Secondary Outcomes

  • Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)(1 year)
  • Prevalence Percentage of Participants with CLL, MM and NHL(1 year)

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