Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: bortezomib

• Registration Number: NCT01021592
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-30
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	bortezomib	-

Primary Outcome Measures

Name	Time	Method
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib	Before the first, after the fourth and at the last IV cycle of bortezomib

Secondary Outcome Measures

Name	Time	Method
Relationship between the primary outcome and the complete remission (CR) rate	Before the first, after the fourth and at the last IV cycle of bortezomib
Adverse events	Every 3 week cycle
Relationship between the primary outcome and the overall response rate	Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the time to response	Before the first, after the fourth and at the last IV cycle of bortezomib