Overview

Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study will observe the degree of the quality of life in non-transplant candidate 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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Korea, Ltd., Korea
Treatments:
Bortezomib
Criteria
Inclusion Criteria:

- Symptomatic multiple myeloma patient

- ECOG score less than 3

- Patient is not a candidate for stem cell transplantation

- Previous treatment duration is less than 6 months

- Previous treatment response is less than partial response (PR)

- Willing and able to complete the questionnaire

- Patients (or their legally acceptable representatives) must have signed an informed
consent document indicating that they understand the purpose of and procedures
required for the study and are willing to participate in the study

Exclusion Criteria:

- Known hypersensitivity to bortezomib

- Acute severe infection requiring antibiotics therapy

- Pre-existing peripheral neuropathy greater than or equal to grade 2

- Uncontrolled or severe cardiovascular disease

- Pregnancy or breastfeeding