Clinical trial NCT02434484: Symbenda Post-Marketing Surveillance (PMS)
Official title: Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Lymphocytic Leukemia
Multiple Myeloma
Keywords: Symbenda
Non-Hodgkin's lymphomas
Chronic lymphocytic leukemia
Multiple myeloma
Bendamustine Hydrochloride
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
timeFrame: Up to 6 months
Secondary outcomes:
measure: Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response
timeFrame: After 2nd cycle (each cycle = 28 days) up to 1.5 months
measure: Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response
timeFrame: After 2nd cycle (each cycle = 28 days) up to 2 months
measure: Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response
timeFrame: After 2nd cycle (each cycle = 28 days) up to 2 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #7
city: Busan
country: Korea, Republic of
facility: Eisai Trial Site #8
city: Daegu
country: Korea, Republic of
facility: Eisai Trial Site #6
city: Daejeon
country: Korea, Republic of
facility: Eisai Trial Site #4
city: Daejeon
country: Korea, Republic of
facility: Eisai Trial Site #5
city: Incheon
country: Korea, Republic of
facility: Eisai Trial Site #9
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #1
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #2
city: Seoul
country: Korea, Republic of
facility: Eisai Trial Site #3
Study officials:
References: