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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01060202
First received: January 29, 2010
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Open-label, Multicenter Observational Study to Evaluate the QoL of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib

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: On day 1 at the first cycle, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between the primary outcome and the complete remission (CR) rate [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Relationship between the primary outcome and overall response [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Relationship between the primary outcome and the time to response [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Relationship between the primary outcome and the survival [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: every 3 week cycle ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bortezomib 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060202

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

Additional Information:
No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01060202     History of Changes
Other Study ID Numbers: CR016750, BOR-KOR-5022
Study First Received: January 29, 2010
Last Updated: July 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Multiple Myeloma
Bortezomib
Velcade
QoL
Proteasome inhibitor
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 April 23, 2014