Status:
COMPLETED
Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Multiple Myeloma
Eligibility:
All Genders
61-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.
Detailed Description
No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma patients are available. Ínterferon tested as consolidation / maintenance therapy has not uniformly proven to pro...
Eligibility Criteria
Inclusion
- Patients who have had pretreatment with single or tandem high dose melphalan therapy and autologous stem cell transplantation as first line therapy
- at least stable disease after stem cell transplantation
- adequate hematological, hepatic and renal lab parameters
- karnofsky status of 70 or more
Exclusion
- non-secretory multiple myeloma
- previous treatment with bortezomib
- allogenic stem cell transplantation
- other co-existing malignancy beside basaliome
- peripheral neuropathy
- epilepsia
- other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious etc.)
- history of allergic reactions to bortezomib or mannitol
- expected life expectancy of less than 3 months
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00416208
Start Date
October 1 2006
End Date
May 1 2013
Last Update
March 5 2015
Active Locations (37)
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1
Bamberg, Germany
2
Berg, Germany
3
Berlin, Germany
4
Bremen, Germany