Clinical trial NCT01060202: Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
Official title: A Prospective, Open-label, Multicenter Observational Study to Evaluate the QoL of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Bortezomib
Velcade
QoL
Proteasome inhibitor
EORTC QLQ C30
EQ 5D
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-transplant candidate patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
timeFrame: On day 1 at the first cycle, 12 weeks, 24 weeks
Secondary outcomes:
measure: Relationship between the primary outcome and the complete remission (CR) rate
timeFrame: 12 weeks and 24 weeks
measure: Relationship between the primary outcome and overall response
timeFrame: 12 weeks and 24 weeks
measure: Relationship between the primary outcome and the time to response
timeFrame: 12 weeks and 24 weeks
measure: Relationship between the primary outcome and the survival
timeFrame: 12 weeks and 24 weeks
measure: Adverse events
timeFrame: every 3 week cycle
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: