Clinical trial NCT01021592: Quality of Life in Multiple Myeloma Patients Treated With Bortezomib
Official title: Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Velcade
QoL
Proteasome inhibitor
Bortezomib
EORTC QLQ C30
EQ 5D
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.

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

Eligibility criteria: 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

Primary outcomes:
measure: The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
timeFrame: Before the first, after the fourth and at the last IV cycle of bortezomib
Secondary outcomes:
measure: Relationship between the primary outcome and the complete remission (CR) rate
timeFrame: Before the first, after the fourth and at the last IV cycle of bortezomib
measure: Relationship between the primary outcome and the overall response rate
timeFrame: Before the first, after the fourth and at the last IV cycle of bortezomib
measure: Relationship between the primary outcome and the time to response
timeFrame: Before the first, after the fourth and at the last IV cycle of bortezomib
measure: Adverse events
timeFrame: Every 3 week cycle
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: