NCT00216697

An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase I/II Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy

An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase I/II study. The other purpose is to evaluate the effectiveness and safety of patients who are re-treated with this drug in recommended dose.

Detailed description

Multiple myeloma is a kind of malignant disease in the organ which produce blood cells such as bone marrow. It has poor prognosis, especially in patients who are relapsed repeatedly. Effective treatment is strongly expected in such relapsed patients in Japan. This is a open label multiple center study to evaluate the effectiveness and safety of bortezomib. This study is an extension or re-treatment study for patients who were administered with bortezomib in preceding Phase I/II study. For extension treatment, the same dose of the previous study will be administered into a vein as a bolus twice weekly followed by a 10-day rest (3-week cycle). For re-treatment, a recommended dose determined in Phase I/II study will be administered in 3-week cycle.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	bortezomib

Timeline

• Start date: 2005-03-01
• Completion: 2006-10-01
• First posted: 2005-09-22
• Last updated: 2011-05-17