Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01021592

Enrollment

140

Registered

2009-11-30

Start date

2007-03-31

Completion date

2008-07-31

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Velcade, QoL, Proteasome inhibitor, Bortezomib, EORTC QLQ C30, EQ 5D

Brief summary

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.

Detailed 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

Interventions

DRUGbortezomib

Injection into a vein 1.3 mg/m2 twice a week for 21 days

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib	Before the first, after the fourth and at the last IV cycle of bortezomib

Secondary

Measure	Time frame
Relationship between the primary outcome and the complete remission (CR) rate	Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the overall response rate	Before the first, after the fourth and at the last IV cycle of bortezomib
Relationship between the primary outcome and the time to response	Before the first, after the fourth and at the last IV cycle of bortezomib
Adverse events	Every 3 week cycle

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026