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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060202
• Other study ID #: CR016750
• Secondary ID: BOR-KOR-5022
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2010
• Last updated: July 16, 2013
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• No intervention
This is an observational study. Patients receiving bortezomib injection intravenously (into a vein) 1.3 mg/m2 twice a week for 21 days will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib		On day 1 at the first cycle, 12 weeks, 24 weeks	No
Secondary	Relationship between the primary outcome and the complete remission (CR) rate		12 weeks and 24 weeks	No
Secondary	Relationship between the primary outcome and overall response		12 weeks and 24 weeks	No
Secondary	Relationship between the primary outcome and the time to response		12 weeks and 24 weeks	No
Secondary	Relationship between the primary outcome and the survival		12 weeks and 24 weeks	No
Secondary	Adverse events		every 3 week cycle	No

External Links

•   A prospective, open-label, multicenter observational study to evaluate the QoL of nontransplant candidate multiple myeloma patients treated with the early bortezomib