An observational study in Multiple Myeloma, sponsored by Janssen Korea, Ltd., Korea. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-23.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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.
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
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 140 is close to the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Drug: bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the complete remission (CR) rate
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the overall response rate
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the time to response
Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib
Adverse events
Time frame: Every 3 week cycle
No study locations are listed for this record.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Janssen Korea, Ltd., Korea