Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416273
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2006-12-22
Brief Title:
A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
Sponsor:
Janssen-Cilag GmbH
Organization:
Janssen-Cilag GmbH
Study Overview
Official Title:
Consolidation Therapy With Bortezomib 60 Year Old Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic myeloma-specific therapy measure up to the occurrence of progressionrecurrence or up to the occurrence of death
Detailed Description:
This is a two-arm group open-label all people know the identity of the intervention prospective a study in which the patients are identified and then followed forward in time for the outcome of the study randomized the study medication is assigned by chance multi-center study Approximately 385 patients will be enrolled in this study Patients will be randomly assigned to treatment or observation group in a ratio of 11 The study duration from screening up to the study end is up to 27 weeks Then the patients will be observed until the last included patient has completed a 30 month post observational phase The patients in the treatment arm will receive 4 cycles of a therapy Each cycle lasts for a 35 days Safety evaluations will include assessment of adverse events vital signs physical examination electrocardiograms and clinical laboratory tests
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 26866138MMY3012 | OTHER | None | None |
| 2005-004948-31 | EUDRACT_NUMBER | Janssen-Cilag GmbH Germany | None |