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NCT Number: NCT01021592

Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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

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

    Time frame: Before the first, after the fourth and at the last IV cycle of bortezomib

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Adverse events

    Time frame: Every 3 week cycle

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2009
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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