Status:
COMPLETED
A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up...
Detailed Description
This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
- Women must be postmenopausal or using safe contraception methods
- Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges
Exclusion
- No asecretory multiple myeloma
- History of allergic reactions to bortezomib or mannitol
- Expected life expectancy of less than 3 months
- No other malignant disease beside basalioma either existing or history of
- No history of severe cardio-pulmonary disease
- Seizures
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00416273
Start Date
December 1 2006
End Date
May 1 2013
Last Update
March 6 2015
Active Locations (38)
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1
Augsburg, Germany
2
Bamberg, Germany
3
Berg, Germany
4
Berlin, Germany