Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib
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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: bortezomib |
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 |
- 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 ]
- 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 |
|---|---|
|
001
bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days
|
Drug: bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days
|
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 |
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.
Inclusion Criteria:
- Symptomatic multiple myeloma patient
- ECOG<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 >=grade 2
- Uncontrolled or severe cardiovascular disease
- Pregnancy or breastfeeding
Contacts and Locations More 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: | December 20, 2012 |
| 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 May 21, 2013