Multiple Myeloma Clinical Trial
Official title:
Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients.
Verified date | April 2014 |
Source | Janssen Korea, Ltd., Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Observational |
The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.
Status | Completed |
Enrollment | 104 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included. Exclusion Criteria: - Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity - Patients with severe hepatic impairment - Women who are pregnant |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Korea, Ltd., Korea |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) | on day 1 at the first cycle, and 12-24 weeks | No | |
Secondary | CR rate | at the end of every 3 week cycle | No | |
Secondary | Overall response rate | at the end of every 3 week cyclet | No | |
Secondary | Correlation between primary endpoints and response rate | 12 -24 weeks | No | |
Secondary | NRS pain score | at the end of every 3 week cycle | No | |
Secondary | Adverse events | at the end of every 3 week cycle | No |
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