Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)
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About
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).
Full description
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
Enrollment
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Inclusion criteria
- Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma
Exclusion criteria
- Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity
- Patients with severe hepatic impairment
- Pregnant women
Trial design
1,121 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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