Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216697
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-09-13
Brief Title:
An Extension Study to Provide Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma Who Previously Participated in a Bortezomib Phase III Study and Who May Benefit From Re-Treatment With or Continuation of Bortezomib Therapy
Sponsor:
Janssen Pharmaceutical KK
Organization:
Janssen Pharmaceutical KK
Study Overview
Official Title:
An Extension or Re-Treatment Study of Bortezomib to Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One purpose of this study is to evaluate the effectiveness and safety in long term treatment for patients who completed preceding phase III 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 III 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 III study will be administered in 3-week cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None