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NCT01021592 Clinical Trial

Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01021592
Other study ID # CR012961
Secondary ID BOR-KOR-11
Status Completed
Phase Phase 4
First received November 25, 2009
Last updated December 22, 2014
Start date March 2007
Est. completion date July 2008

Study information
Verified date December 2014
Source Janssen Korea, Ltd., Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Janssen Korea, Ltd., Korea

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Relationship between the primary outcome and the overall response rate Before the first, after the fourth and at the last IV cycle of bortezomib No
Secondary Relationship between the primary outcome and the time to response Before the first, after the fourth and at the last IV cycle of bortezomib No
Secondary Adverse events Every 3 week cycle No
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1

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