Overview

A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
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 to the occurrence of progression/recurrence or up to the occurrence of death.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag G.m.b.H
Treatments:
Bortezomib
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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