Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Study Overview
=================
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

Official Title
-----------------
Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: bortezomib


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br> | Drug: bortezomib<br>* Injection into a vein 1.3 mg/m2 twice a week for 21 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Adverse events |  | Every 3 week cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Velcade, QoL, Proteasome inhibitor, Bortezomib, EORTC QLQ C30, EQ 5D