Symbenda Post-Marketing Surveillance (PMS)

Sponsor

Eisai Korea Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02434484

Collaborator

(none)

Enrollment

Locations

20.5

Actual Duration (Months)

9.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Lymphocytic Leukemia Multiple Myeloma

Study Design

Study Type:

Observational

Actual Enrollment :

84 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 4, 2018

Actual Primary Completion Date :

Mar 20, 2020

Actual Study Completion Date :

Mar 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Symbenda Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.

Outcome Measures

Primary Outcome Measures

Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions [Up to 6 months]
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.

Secondary Outcome Measures

Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response [After 2nd cycle (each cycle = 28 days) up to 1.5 months]
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.
Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response [After 2nd cycle (each cycle = 28 days) up to 2 months]
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.
Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response [After 2nd cycle (each cycle = 28 days) up to 2 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Eisai Trial Site #7	Busan	Korea, Republic of
2	Eisai Trial Site #8	Busan	Korea, Republic of
3	Eisai Trial Site #6	Daegu	Korea, Republic of
4	Eisai Trial Site #4	Daejeon	Korea, Republic of
5	Eisai Trial Site #5	Daejeon	Korea, Republic of
6	Eisai Trial Site #9	Incheon	Korea, Republic of
7	Eisai Trial Site #1	Seoul	Korea, Republic of
8	Eisai Trial Site #2	Seoul	Korea, Republic of
9	Eisai Trial Site #3	Seoul	Korea, Republic of