Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: bortezomib

Study type: Observational

Funder types: Industry

Identifiers

NCT01021592

BOR-KOR-11

CR012961

Details and patient eligibility

About

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.

Full 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

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 1 patient group

001

Treatment:

Drug: bortezomib