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