An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center