Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416208
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2006-12-22
Brief Title:
Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma
Sponsor:
Janssen-Cilag GmbH
Organization:
Janssen-Cilag GmbH
Study Overview
Official Title:
Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75
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 to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75
Detailed Description:
No data supporting the use of bortezomib as a consolidation therapy in multiple myeloma patients are available Ínterferon tested as consolidation maintenance therapy has not uniformly proven to prolong survival In this study the hypothesis is being tested that bortezomib is able to increase duration of response and thus improving survival This hypothesis is based on the results of the approval study where bortezomib has been tested to improve these endpointsThis is a multicenter open-label randomized patients are assigned to different treatment group by chance phase III study to evaluate the efficacy and safety of a consolidation therapy with bortezomib in patients with multiple myeloma aged 61 to 75 Three months after receiving high dose melphalan with autologous stem cell transplantation patients will be randomized to receive either consolidation therapy with bortezomib or to be monitored without consolidation therapy Subjects in the consolidation group will be treated up to 4 cycles 6 weeks each The main study phase has a duration of 24 weeks The trial ends after the last enrolled patient has completed a follow-up period of 30 months The primary objective is to determine the event free survival in treatment and observation group The secondary objectives are to assess the response rate overall survival duration of response time to progression short- and long-term toxicities quality of life and cytogenetic analyses with regard to treatment response event free survival and overall survival Primary efficacy analysis Event free survival is defined as the time from the first disease-related therapeutic procedure until death progress or relapse Secondary efficacy analyses response rate of the treatment group measured by the relative change of M-protein levels in serum or urine overall survival is defined as the time from the first therapeutic procedure until death time to progression is defined as the duration from the date of enrolment until the date of first documented evidence of progressive disease or relapse duration of response is defined as the duration in months from the date of first evidence of confirmed response to the date of first documented evidence of progressive disease or relapse quality of life is assessed by the questionnaires EORTC QLQ-C30 Quality of life questionnaire and EORTC EQ-5D Euro Quality of life Consolidation therapy lasts 4 cycles Subjects will be treated with bortezomib 16 mgm2 body surface intravenously once weekly for 4 weeks Days 1 8 15 and 22 followed by a 13-day rest period days 23 to 35 At least 72 hours should relapse between consecutive doses of bortezomib Therapy should be withheld at the onset of any Grade 3 nonhematological or Grade 4 hematological toxicities excluding neuropathy
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 |
|---|---|---|---|
| 26866138MMY3013 | OTHER | Janssen-Cilag GmbH Germany | None |