Symbenda Post-Marketing Surveillance (PMS)

Eisai Korea Inc.84 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lymphoma, Non-Hodgkin Lymphocytic Leukemia Multiple Myeloma

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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: 1. Patients with approved indication for Symbenda in Korea 2. 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.

Locations (9)

Eisai Trial Site #7

Busan, South Korea

Eisai Trial Site #8

Busan, South Korea

Eisai Trial Site #6

Daegu, South Korea

Eisai Trial Site #4

Daejeon, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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