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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: March 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Drug: bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021592

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01021592     History of Changes
Other Study ID Numbers: CR012961, BOR-KOR-11
Study First Received: November 25, 2009
Last Updated: April 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Velcade
QoL
Proteasome inhibitor
Bortezomib
EORTC QLQ C30
EQ 5D

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014