Multiple Myeloma Clinical Trial
Official title:
Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
Verified date | December 2014 |
Source | Janssen Korea, Ltd., Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | 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.
Status | Completed |
Enrollment | 140 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Korea, Ltd., Korea |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | Relationship between the primary outcome and the overall response rate | Before the first, after the fourth and at the last IV cycle of bortezomib | No | |
Secondary | Relationship between the primary outcome and the time to response | Before the first, after the fourth and at the last IV cycle of bortezomib | No | |
Secondary | Adverse events | Every 3 week cycle | No |
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