Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01021592
First received: November 25, 2009
Last updated: April 24, 2014
Last verified: April 2014

November 25, 2009
April 24, 2014
March 2007
February 2009   (final data collection date for primary outcome measure)
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib [ Time Frame: Before the first, after the fourth and at the last IV cycle of bortezomib ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021592 on ClinicalTrials.gov Archive Site
  • Relationship between the primary outcome and the complete remission (CR) rate [ Time Frame: Before the first, after the fourth and at the last IV cycle of bortezomib ] [ Designated as safety issue: No ]
  • Relationship between the primary outcome and the overall response rate [ Time Frame: Before the first, after the fourth and at the last IV cycle of bortezomib ] [ Designated as safety issue: No ]
  • Relationship between the primary outcome and the time to response [ Time Frame: Before the first, after the fourth and at the last IV cycle of bortezomib ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Every 3 week cycle ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Among 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.

Multiple Myeloma
Drug: bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days
001
Intervention: Drug: bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01021592
CR012961, BOR-KOR-11
Yes
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP