NCT02434484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
3.2 years until next milestone

Study Start

First participant enrolled

July 4, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

April 28, 2015

Last Update Submit

January 25, 2021

Conditions

Lymphoma, Non-HodgkinLymphocytic LeukemiaMultiple Myeloma

Keywords

SymbendaNon-Hodgkin's lymphomasChronic lymphocytic leukemiaMultiple myelomaBendamustine Hydrochloride

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Symbenda

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Patients with approved indication for Symbenda in Korea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Eisai Trial Site #7

Busan, South Korea

Location

Eisai Trial Site #8

Busan, South Korea

Location

Eisai Trial Site #6

Daegu, South Korea

Location

Eisai Trial Site #4

Daejeon, South Korea

Location

Eisai Trial Site #5

Daejeon, South Korea

Location

Eisai Trial Site #9

Incheon, South Korea

Location

Eisai Trial Site #1

Seoul, South Korea

Location

Eisai Trial Site #2

Seoul, South Korea

Location

Eisai Trial Site #3

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, LymphoidMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemiaHematologic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 5, 2015

Study Start

July 4, 2018

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

KR(9)