Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
A Prospective, Open-label, Multicenter Observational Study to Evaluate the QoL of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
2 other identifiers
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJuly 17, 2013
July 1, 2013
1.7 years
January 29, 2010
July 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Relationship between the primary outcome and the complete remission (CR) rate
12 weeks and 24 weeks
Relationship between the primary outcome and overall response
12 weeks and 24 weeks
Relationship between the primary outcome and the time to response
12 weeks and 24 weeks
Relationship between the primary outcome and the survival
12 weeks and 24 weeks
Adverse events
every 3 week cycle
Study Arms (1)
Bortezomib
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
November 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 17, 2013
Record last verified: 2013-07