Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
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
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
Outcome Time Frame:
Before the first, after the fourth and at the last IV cycle of bortezomib
Safety Issue:
No
Principal Investigator
Janssen Korea, Ltd. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Korea, Ltd.
Authority:
Korea: Food and Drug Administration
Study ID:
CR012961
NCT ID:
NCT01021592
Start Date:
March 2007
Completion Date:
February 2009
Related Keywords:
- Multiple Myeloma
- Velcade
- QoL
- Proteasome inhibitor
- Bortezomib
- EORTC QLQ C30
- EQ 5D
- Multiple Myeloma
- Neoplasms, Plasma Cell
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