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
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma|
- No. of patients who had adverse events, incidence and severity of adverse events, and relationship to the study drug. Overall response rate (Complete Remission + Partial Remission). Response will be evaluated by independent review committee.
- TTP (Time To Progression), survival time, time to response and duration of response. For re-treatment patients, survival time from the previous study drug treatment and response rate from the start of re-treatment will be also evaluated.
|Study Start Date:||March 2005|
|Study Completion Date:||October 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216697
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|