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Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

NCT ID: NCT01021592

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-07-31

Brief Summary

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This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.

Detailed Description

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Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered

Conditions

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Multiple Myeloma

Keywords

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Velcade QoL Proteasome inhibitor Bortezomib EORTC QLQ C30 EQ 5D

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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001

bortezomib

Intervention Type DRUG

Injection into a vein 1.3 mg/m2 twice a week for 21 days

Interventions

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bortezomib

Injection into a vein 1.3 mg/m2 twice a week for 21 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma
* Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included

Exclusion Criteria

* Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity
* Patients with severe hepatic impairment
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=312&filename=CR012961_CSR.pdf

Evaluation in Improvement of Quality of Life in Patients with Multiple Myeloma Using Velcade® (bortezomib)

Other Identifiers

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BOR-KOR-11

Identifier Type: -

Identifier Source: secondary_id

CR012961

Identifier Type: -

Identifier Source: org_study_id