Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT00216697

Conditions

Multiple Myeloma

Interventions

bortezomib

Study Description

Brief 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.