Trial Information

A Prospective, Open-label, Multicenter Observational Study to Evaluate the QoL of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib

Multiple myeloma (MM) is a plasma cell malignancy with progression marked by symptoms and
signs of lowered resistance to infection, skeletal destruction, renal failure, and anemia.
It is incurable and follows a relapsing course, with a median survival of approximately 4-5
years. The various therapies associated with disease control, are often associated with
significant side effects, and ultimately, patients relapse. Therefore, assessment of
health-related quality of life (HRQL) represents an important tool for evaluating the value
of effective therapies when weighed against the potential toxic effects of treatment from
the patient's perspective. Patients diagnosed with MM suffer from pain, fatigue, reduced
physical and role functioning, and reduced overall HRQL compared with an age- and
gender-matched population. These symptoms can improve with successful treatment with either
cytotoxic therapy or supportive care. 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 the quality of life of patients in the early status of 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