Status:
COMPLETED
Retrospective Survey of Re-treatment With Bortezomib
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Hematological Cancer
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were ...
Detailed Description
This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responde...
Eligibility Criteria
Inclusion
- Has a current diagnosis/was diagnosed with MM or secretory MM
- Was previously treated with bortezomib-containing chemotherapy
- Responded to bortezomib as first-line treatment
- Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months
- Completed bortezomib re-treatment at least 2 months ago
Exclusion
- Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade
- Has received bortezomib-containing chemotherapy for the first time following a first relapse or later
- Has participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study
- Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01524445
Start Date
March 1 2011
End Date
October 1 2011
Last Update
June 12 2012
Active Locations (4)
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1
Alexandroupoli, Greece
2
Athens, Greece
3
Athens Attica, Greece
4
Pátrai, Greece