Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Velcade - Regulatory Post Marketing Surveillance (PMS)

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days | Drug: bortezomib<br>* Injection into a vein 1.3 mg/m2 twice a week for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type |  | every cycles or every 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria. |  | every cycle or every 3 weeks and end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib postmarketing surveillance, Korea bortezomib PMS