Trials / Completed
CompletedNCT01030302
A Retreatment Study With Bortezomib for Multiple Myeloma
An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- Janssen Korea, Ltd., Korea · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bortezomib | bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-09-01
- Completion
- 2010-09-01
- First posted
- 2009-12-11
- Last updated
- 2013-03-08
Source: ClinicalTrials.gov record NCT01030302. Inclusion in this directory is not an endorsement.