Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464178
Status:
TERMINATED
Last Update Posted:
2022-07-20
First Post:
2007-04-19
Brief Title:
A Phase II Study of Bevacizumab and Bortezomib in Patients With RelapsedRefractory Multiple Myeloma
Sponsor:
Hackensack Meridian Health
Organization:
Hackensack Meridian Health
Study Overview
Official Title:
A Phase II Study of Bevacizumab and Bortezomib in Patients With Relapsed Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed early due to poor accrual
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 determine whether the combination of bevacizumab and bortezomib have increased efficacy in the treatment of relapsed refractory multiple myeloma
Detailed Description:
Rationale With the identification of thalidomide as an active agent in Multiple Myeloma the role of angiogenesis in its pathogenesis has become a subject of much investigation Micro vessel density neovascularization is inversely related to prognosis in Multiple Myeloma Response to thalidomide was felt to correlate with a decline in microvessel density Singhal et al NEJM While the mechanism of neovascularization is yet to be fully elucidated a number of models have shown VEGF to play a central role
Thalidomide has been shown to synergize with a number of agents used to treat MM including bortezomib Wang et al ASH 2005 This would justify the use of other therapeutics with known antiangiogenic activity in conjunction with established antimyeloma therapies
Bortezomib which has the precedence of known synergy with Thalidomide and has an extremely well established optimal dose schedule response rate event free survival and overall survival would make it an excellent candidate for combination therapy with other established antiangiogenic compounds
There have been several reports of the role of VEGF in multiple myeloma It has been shown that multiple myeloma cells secreteVEGF which further promotes production of IL-6 in BMSCs as well as migration and proliferation of the tumor cells Thus VEGF is both an autocrine growth factor and trigger of IL-6-mediated paracrine multiple myeloma cell growth Recent reports have highlighted the major role of VEGF in multiple myeloma pathogenesis demonstrating the VEGF also increases microvessel density in the bone marrow VEGF also inhibits dendritic cells Taken together these preclinical reports make strong suggestion for the promise of VEGF targeted agents in multiple myeloma Le Gouill et al 2004
Thalidomide has been shown to synergize with a number of agents used to treat MM including bortezomib Wang et al ASH 2005 This would justify the use of other therapeutics with known antiangiogenic activity in conjunction with established antimyeloma therapies
Bortezomib which has the precedence of known synergy with Thalidomide and has an extremely well established optimal dose schedule response rate event free survival and overall survival would make it an excellent candidate for combination therapy with other established antiangiogenic compounds
There have been several reports of the role of VEGF in multiple myeloma It has been shown that multiple myeloma cells secreteVEGF which further promotes production of IL-6 in BMSCs as well as migration and proliferation of the tumor cells Thus VEGF is both an autocrine growth factor and trigger of IL-6-mediated paracrine multiple myeloma cell growth Recent reports have highlighted the major role of VEGF in multiple myeloma pathogenesis demonstrating the VEGF also increases microvessel density in the bone marrow VEGF also inhibits dendritic cells Taken together these preclinical reports make strong suggestion for the promise of VEGF targeted agents in multiple myeloma Le Gouill et al 2004
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 |
|---|---|---|---|
| AVF3502s | OTHER | None | None |
| 20070359 | OTHER | WIRB no | None |