Multiple MyelomaNCT01005628
Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)
An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- bortezomib
- Type of treatment
- Injection or infusion
- How many people
- 1,121 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma in Korea
Who may be able to join
- Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Velcade - Regulatory Post Marketing Surveillance (PMS)
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).
Read the detailed 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
- Conditions
- Multiple Myeloma
- Being tested
- bortezomib
- Keywords
- Bortezomib postmarketing surveillance, Korea bortezomib PMS
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Injection into a vein 1.3 mg/m2 twice a week for 21 days
| Study group | Role | What they receive |
|---|---|---|
| 001 | bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days Receives: Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
Measured: every cycles or every 3 weeks
Secondary outcomes (1)
The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.
Measured: every cycle or every 3 weeks and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJun 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005628
- Sponsor's protocol ID
- CR012958
- Other IDs
- bortezomib PMS
- Status last verified
- Feb 2013
- First submitted
- 29 Oct 2009
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade - Regulatory Post Marketing Surveillance (PMS)
- ClinicalTrials.gov ID
- NCT01005628
- Acronym / sponsor ID
- CR012958
- Conditions
- Multiple Myeloma
- Keywords
- Bortezomib postmarketing surveillance, Korea bortezomib PMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: bortezomibbortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma in Korea
Key inclusion criteria (1 listed)
- Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomibInjection into a vein 1.3 mg/m2 twice a week for 21 days | Drug | 001 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.