Symbenda Post-Marketing Surveillance (PMS)

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434484
• Other study ID #: B0501-M065-501
• Status: Completed
• Start date: July 4, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: January 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Lymphocytic Leukemia
• Lymphoma, Non-Hodgkin
• Multiple Myeloma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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