An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma
Trial Information
An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma
It will be essential to obtain the Korean clinical data about the efficacy and safety of the
re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is
a prospective, multi-center, Phase 4, observational study that will be conducted to collect
such demographic data as a past history, a previous history of drug use, the degree of
responses to initial treatment, the frequency of previous therapies, age, Eastern
Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used
for re-treatment and the pattern of treatment for patients with multiple myeloma and who
were re-treated with injectable bortezomib. Also safety data will be collected.
Observational Study -No investigational drug administered
Inclusion Criteria:
- Patients with multiple myeloma
- Patients who were treated with bortezomib monotherapy or bortezomib combination
therapy
- Patients who relapsed after >= six months interval since last dose of bortezomib
- Patients who had a treatment response of higher than partial remission (PR) to the
previous bortezomib therapy
- Patients who were fully aware of the objectives and essential procedures of the
current trial and then submitted a written informed consent declaring that they will
voluntarily participate in the current trial
Exclusion Criteria:
- The current presence of or a past history of hypersensitivity to bortezomib or its
constituents
- Severe hepatic dysfunction (AST or ALT at first use>= x 5 upper normal)
- Pregnant women
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment.
Outcome Time Frame:
6-12 months
Safety Issue:
No
Principal Investigator
Janssen Korea, Ltd. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Korea, Ltd.
Authority:
Korea: Food and Drug Administration
Study ID:
CR015814
NCT ID:
NCT01030302
Start Date:
November 2008
Completion Date:
September 2010
Related Keywords:
- Multiple Myeloma
- Bortezomib retreatment
- Velcade
- Proteasome inhibitor
- Bortezomib
- Multiple Myeloma
- Neoplasms, Plasma Cell
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