An observational study in Multiple Myeloma, sponsored by Janssen Korea, Ltd., Korea. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-20.
Sponsored by Janssen Korea, Ltd., Korea (part of Johnson & Johnson) · Observational
After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).
After the KFDA approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade). We will collect the response rate according to the EMBT (European Group for Blood and Marrow Transplant; a non-profit organization based in the Netherlands that promotes the transplantation of haemopoietic stem cells from all donor sources and donor types and related basic and clinical research, education, standardization, quality control, and accreditation for transplant procedures) or IMWG (the International Myeloma Working Group) criteria and the adverse events to assess the efficacy and safety. Observational Study - No investigational drug administered
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 1,121 is above the median of 145 across 482 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen Korea, Ltd., Korea is the lead sponsor of 79 studies on the registry; 3 are open to participants now.
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Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma in Korea
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
Time frame: every cycles or every 3 weeks
The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.
Time frame: every cycle or every 3 weeks and end of treatment
The record gives a start of Jun 2006, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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