Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431769
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2007-02-02
Brief Title:
An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma
Sponsor:
Janssen-Cilag International NV
Organization:
Janssen-Cilag International NV
Study Overview
Official Title:
A Phase II Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade
Status:
COMPLETED
Status Verified Date:
2014-05
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 to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy
Detailed Description:
This is an Open-Label all people know the identity of the intervention non-randomized multicenter when more than one hospital or medical school team work on a medical research study single arm study to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma cancer of the types of cells normally found in bone marrow who have previously responded to a bortezomib based therapy Participants will be non-randomly assigned to single group bortezomib Participants will be treated with bortezomib alone or in combination with another drug dexamethasone Bortezomib will be given intravenously iv into a vein twice Weekly on Days 1 4 8 and 11 of each cycle followed by a 10-day Days 12 to 21 rest period The total duration of treatment period will be 8 cycles each lasting 3 weeks The initial bortezomib dose is the last tolerated dose 10 or 13 milligram per metersquare mg m2 on the previous bortezomib-based treatment Participants who start the study on a dose of 10 mgm2 bortezomib and tolerate the dose well could have their dose escalated to 13 mgm2 Doses above 13 mgm2 are not allowed A complete cycle comprises 4 doses of bortezomib Dexamethasone will be first introduced in Cycles 1 to 5 iedexamethasone will not be introduced for the first time in Cycles 6 to 8 The median total dose of dexamethasone received per cycle ranges from 120 mg cycle 7 to 160 mg cycles 1 to 6 and 8 Efficacy will be primarily assessed by determining Best Confirmed Response according to the European Group for Blood and Marrow Transplantation EBMT criteria Participants safety will be monitored throughout the study
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 |
|---|---|---|---|
| 2005-005819-26 | EUDRACT_NUMBER | Janssen-Cilag International NV | None |
| 26866138MMY2036 | OTHER | None | None |