Symbenda Post-Marketing Surveillance (PMS)

Study Overview
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Brief Summary
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This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.

Official Title
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Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients

Conditions
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Lymphoma, Non-Hodgkin, Lymphocytic Leukemia, Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study. This study will be conducted as complete surveillance method; subjects who meet the inclusion/exclusion criteria and administrate Symbenda for the first time after conclusion of agreement will be enrolled. Inclusion Criteria: Patients who meet the following criteria will be eligible for inclusion in the study: Patients with approved indication for Symbenda in Korea Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria. Exclusion Criteria: Investigators will refer to approved indications and contraindications regarding exclusion criteria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symbenda<br>Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions | An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response | Non-Hodgkin's lymphoma(NHL) is a cancer that starts in cells called lymphocytes, which are part of the body's immune system. Lymphocytes are in the lymph nodes and other lymphoid tissues (such as the spleen and bone marrow). Non-hodgkin's lymphoma is classified with two broad categories, such as high-grade or aggressive and low-grade or indolent. Response criteria for non-Hodgkin's lymphomas will be used to assess tumor response. | After 2nd cycle (each cycle = 28 days) up to 1.5 months | 
| Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response | Chronic lymphocytic leukemia is a type of cancer that starts from cells that become lymphocytes in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then migrate into the blood. NCISWG criteria will be used to assess tumor response. | After 2nd cycle (each cycle = 28 days) up to 2 months | 
| Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response | Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. IMWG Uniform Response Criteria will be used to assess tumor response. | After 2nd cycle (each cycle = 28 days) up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbenda, Non-Hodgkin's lymphomas, Chronic lymphocytic leukemia, Multiple myeloma, Bendamustine Hydrochloride