Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

NCT01021592 | Completed DMC

• 2 other identifiers: CR012961BOR-KOR-11
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

Velcade; QoL; Proteasome inhibitor; Bortezomib; EORTC QLQ C30; EQ 5D

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

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

Secondary Outcomes (4)

• Relationship between the primary outcome and the complete remission (CR) rate

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

• Relationship between the primary outcome and the overall response rate

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

• Relationship between the primary outcome and the time to response

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

• Adverse events

  Every 3 week cycle

Study Arms (1)

001

Drug: bortezomib

Interventions

bortezomib DRUG

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

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Links

• Evaluation in Improvement of Quality of Life in Patients with Multiple Myeloma Using Velcade® (bortezomib)

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 23, 2014

Record last verified: 2014-12