The Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN)
|ClinicalTrials.gov Identifier: NCT01171443|
Recruitment Status : Unknown
Verified July 2010 by Wolfson Medical Center.
Recruitment status was: Not yet recruiting
First Posted : July 28, 2010
Last Update Posted : July 28, 2010
|Condition or disease|
The proteasome inhibitor bortezomib has shown impressive clinical activity alone and in combination with other novel agents for the treatment of multiple myeloma (MM).
Peripheral neuropathy is a significant dose limiting toxicity of bortezomib, which typically occurs within the first treatment cycles with bortezomib, reaching plateau around cycle 5, and does not appear to increase thereafter.
Although bortezomib is known to be selective proteasome inhibitor, the mechanisms of cytotoxicity are poorly understood.
It has been theoretically hypothesized that bortezomib abrogates the degradation of I-kB, which blocks the transcriptional activity of NF-kB, however, recent studies demonstrated that bortezomib elicits activation of multiple pathways in cancer cells, such as reactive oxygen species (ROS) pathway.
The involvement of oxidative stress is supported by emerging studies showing that ROS generation plays a critical role in the initiation of the bortezomib induced apoptotic cascade.
Oxidative stress is a complex and dynamic situation characterized by an imbalance between the productions of ROS and the availability and action of antioxidants.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Is There a Role of Oxidative Stress in the Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients?|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171443
|Contact: Ghoti Hossamfirstname.lastname@example.org|
|Wolfsson Medical Center||Not yet recruiting|
|Contact: GHOTI HOSSAM 970-35028110 email@example.com|
|Principal Investigator:||GHOTI HOSSAM||HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER|