Consolidation Therapy With Bortezomib in Elderly 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 to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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